pharmchemical.com, ZHOU XI FEN PHARM CHEMICAL, Product Quality II

PRODUCT QUALITY (Certificate of Analysis) (In alphabetical sequence) ( A ----> K )　( L ----> Z )
ZXFPC0300 Lacidipine CAS Number: 103890-78-4 Lacidipine Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Melting range: 175--179℃ 176.0-178.0℃ Chloride: ≤0.02％ <0.02% Sulfate: ≤0.05％ <0.05% Related substances: ≤0.5％ <0.5% Loss on drying: ≤0.5％ 0.3% Residue on ignition: ≤0.2％ 0.05% Heavy metals: ≤0.001% <0.001% Assay: 98.5-102.0% 99.2% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0302 Lamivudine (3TC) CAS Number: 134678-17-4 Lamivudine Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of USP27 Conforms Melting point: 174.0-178.0℃ 176.7-177.6℃ Specific rotation: -140.0?-- -145.0? -142.61? Heavy Metals: ≤20ppm <20ppm Sulphated Ash: ≤0.2％ 0.02% Loss on drying: ≤0.5% 0.07% Related Substance (HPLC): ≤1.0% <1.0% Assay(HPLC): 98--102.0% 99.91% Conclusion: The Specification conforms to the rule of USP27.
ZXFPC0303 Lamotrigine CAS Number: 84057-84-1 Lamotrigine Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Solubility: Rule of ES Conforms Melting point: 215--219℃ 216--217℃ Loss on drying: ≤0.5% 0.1% Heavy Metals: ≤20ppm <20ppm Residue on Ignition: ≤0.1％ 0.07% Organic Volatile Impurity: Methanol ≤1000ppm Conforms Ethanol ≤1000ppm Conforms Related Substance: Any individual impurity: ≤0.2% Conforms Total impurities: ≤0.5% Conforms Assay: 99.0--101% 99.8% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0307 Leflunomide CAS Number: 75706-12-6 Leflunomide Appearance: White or off-white crystalline powder Quality Index Standard Results Residue on ignition: ≤0.5％ 0.07% Heavy metals: ≤0.001% 5ppm Loss on drying: ≤0.5％ 0.15% Melting point: 164--168℃ 166-167℃ 3-Methyl Isomeric Compound:≤0.5％ 0.18% Total Impurities: ≤1.0％ 0.60% Assay: ≥98.0% 99.2% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0309 Leucovorin Calcium CAS Number: 1492-18-8 Leucovorin Calcium Appearance: Yellowish to yellow crystalline or amorphous powder Quality Index Standard Results Identification: Rule of USP28 Conforms Water: ≤17.0% 12.57% Solubility: Rule of USP28 Conforms Color of solution: ≤Y7 Y3 PH: 6.5-6.8 6.7 Heavy Metals: ≤0.005% Conforms Assay: 95.0-105.0% 99.8% Conclusion: The Specification conforms to the rule of USP28/BP2002.	ZXFPC0312 Levetiracetam CAS Number: 102767-28-2 Levetiracetam Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Melting point: 114--118℃ 115.0-116.5℃ Specific rotation: -85?-- -95? -89.8? Loss on drying: ≤1.0% 0.15% Residue on ignition: ≤0.1% 0.05% Heavy metals: ≤20ppm <20ppm Sulphated Ash: ≤0.02% <0.02% Related substances: Rule of ES Conforms Assay: 98.0---102.0% 99.1% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0317 Linezolid CAS Number: 165800-03-3 Linezolid Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Specific rotation: -9.0?-- -15.0? -10.87? Loss on drying: ≤0.5% 0.1% Heavy metals: ≤10ppm <10ppm Residue on ignition: ≤0.1% Conforms Assay: 98.0---102.0% 99.54% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0319 Lisinopril Dihydrate CAS Number: 83915-83-7 Lisinopril Appearance: A white crystalline powder, very soluble in water, sparingly soluble in methanol, practically insoluble in acetone and in ethanol. Quality Index Standard Results Identification: Rule of USP24 Conforms Specific rotation(405nm) : -115.3°-- -122.5° -121.1° Water: 8.0-9.5% 8.63% Residue on ignition: ≤0.1% 0.07% Heavy metals: ≤0.001% <0.001% Related substances (HPLC): R.S.S-Isomer: ≤0.3% 0.17% N-(1-carboxy-3-phenylpropyl)-L-Lysine:≤0.2% 0.06% Any unknown impurity: ≤0.1% <0.1% All unknown impurities: ≤0.5% 0.21% Assay: 98--102% 99.44% Microbial Limit Test: Total aerobic microbial count: ≤500/g 200/g Total combined yeasts and molds count: ≤100/g 10/g Escherichia coli: Couldn't be detected N.D. Salmonella species Couldn't be detected N.D. Conclusion: The Specification conforms to the rule of USP24.
ZXFPC0327 Loratadine CAS Number: 79794-75-5 Loratadine Appearance: White crystalline powder Quality Index Standard Results E1%( In 280nmE1%): 237--251 Conform Identification: Enterprise Standard Conform Chloride: ≤20ppm Conform Loss on drying: ≤0.5％ 0.1% Melting point: 132--137℃ 134.8-136.0℃ Ash: ≤0.1％ 0.04% Heavy metals: ≤20ppm Conform Residual solvent: ≤0.01％ Conform Any impurities: ≤1.0％ 0.2% Total impurities: ≤1.5％ 0.47% Assay: ≥99.0% 99.43% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0328 Losartan Potassium CAS Number: 114798-26-4 Losartan Potassium Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of USP28 Conforms Loss on drying: ≤0.5% 0.39% Heavy metals: ≤10ppm <10ppm Chromatographic Purity: Individual impurity: ≤0.2% 0.05% Total impurity: ≤0.5% 0.12% Residual Solvents: Cyclohexane: ≤0.1% 0.01% Isopropyl alcohol: ≤0.2% 0.05% Assay: 98.5---101.0% 99.9% Conclusion: The Specification conforms to the rule of USP28.
ZXFPC0330 Low Molecular Weight Heparin (LMWH) Low Molecular Weight Heparin (LMWH) Appearance: White Powder Quality Index Standard Results Identification: Rule of ES Conforms PH: 5.5-7.5 6.41 Solubility: Rule of ES Conforms Loss on drying: ≤10.0% 5.30% Nitrite: Rule of ES Conforms Solubility: Rule of ES Conforms Heavy Metals: ≤30ppm <30ppm Microorganism: Rule of ES Conforms Assay (on dry basis): 40-60IU/mg 49.2IU/mg Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0336 Mecobalamin /Vitamin B12 CAS Number: 13422-55-4 Mecobalamin (methylcobalamin) Appearance: Dark red crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Moisture: ≤12.0% 3.92% Solution purity: Clear and red color Conforms Assay: >98.0% 99.80% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0338 Meglumine Antimoniate CAS Number: Base 6284-40-8 N-Meglumine Antimoniate Appearance: White powder Quality Index Standard Results Identification: Rule of ES Conforms Solubility: Rule of ES Conforms PH: 5.0-8.0 5.05 N content: 3.6-4.6% 3.70% Sb content: 32.0---37.0% 36.48% Cl- content: ≤1.0% 0.10% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0341 Mequitazine CAS Number: 29216-28-2 Mequitazine Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of JPXIV Conforms Melting point: 146--150℃ 146.6-147.0℃ Heavy Metals: ≤20ppm <20ppm Loss on drying: ≤0.5% 0.02% Residue on Ignition: ≤0.1％ 0.03% Assay: >98.5% 99.1% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0345 Methotrexate Disodium CAS Number: 15475-56-6 / Base 59-05-2 Methotrexate Appearance: Orange to yellow crystalline powder Quality Index Standard Results Identification: Rule of USP24 Conforms Specific rotation: +19.0°-- +24.0° Conforms Loss on drying: ≤12.0% Conforms Residue on Ignition: ≤0.1％ 0.04% Related Substance: Any individual impurity: ≤0.5% Conforms Total impurities: ≤2.0% Conforms Assay: 98.0-102.0% 99.3% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0348 Micronomicin Sulfate CAS Number: 66803-19-8 Micronomicin Sulfate Appearance: Off-white crystalline powder Quality Index Standard Results Identification: Rule of JAE86/JAE90 Conforms Specific rotation: +115°-- +119° +117.10° PH: 3.5---6 4.6 Solution Color: <YG2 Conforms Loss on drying: ≤5.0％ 4.0% Residue on Ignition: ≤0.1％ 0.05% Other substance: Rule of JAE86/JAE90 Conforms Assay: ≥550u/mg 579u/mg Assay (On dry basis): ≥580u/mg 603u/mg Conclusion: The Specification conforms to the rule of JAE86/JAE90.
ZXFPC0349 Midecamycin CAS Number: Acetate 55881-07-7 Midecamycin Appearance: White or offt-white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Loss on drying: ≤2.0% 1.65% Residue on Ignition: ≤0.5% 0.04% Heavy Metals: ≤30ppm Conforms Assay: ≥900u/mg 921u/mg Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0350 Milrinone CAS Number: 78415-72-2 Milrinone Appearance: Off-White crystalline powder Quality Index Standard Results Identification: Rule of ES/USP28 Conforms Residue on Ignition: ≤0.2％ 0.05% Heavy Metals: ≤20ppm <20ppm Water: ≤1.0% 0.75% Related Substance: Individual unknown: ≤0.1% 0.05% Individual known: ≤0.2% 0.07% Total impurities: ≤0.5% 0.12% Related Solvent: Ethanol: ≤1500ppm 1385ppm Ether: ≤100ppm <23ppm DMF: ≤250ppm <38ppm Organic Volatile impuritites: ≤60ppm <30ppm Assay: 98.5--101.5% 99.3% Conclusion: It conforms to the rule of Enterprise Standard / USP28.
ZXFPC0353 Minoxidil CAS Number: 38304-91-5 MINOXIDIL Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of USP26 Conforms Residue on ignition: ≤0.5％ 0.08% Heavy metals: ≤20ppm <10ppm Loss on drying: ≤0.5％ 0.21% Organic Volatile Impurities: Rule of USP24 Conforms Total impurities: ≤1.5％ <0.70% Assay: 97.0-103.0% 99.32% Conclusion: The Specification conforms to the rule of USP26.	ZXFPC0360 Moexipril CAS Number: 103775-10-6 Moexipril Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Specific rotation: +32.0°-- +35.0° +33.7° PH: 2.0-3.0 2.37 Loss on drying: ≤1.0% 0.24% Residue on Ignition: ≤0.5％ 0.19% Heavy Metals: ≤10ppm <10ppm Related Substance: ≤2.0% 0.89% Assay: 98.0-101.0% 99.4% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0371 Natamycin 50 PCT Minimum + Lactose CAS Number: 7681-93-8 Natamycin 50 PCT Minimum + Lactose Appearance: White to yellow crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Moisture: ≤8.0% 6.4% PH: 5-7.5 6.6 Solution Color: ≤0.07% 0.04% ASH: ≤0.5% 0.4% Pb: ≤5ppm Conforms As: ≤3ppm Conforms Hg: ≤1ppm Conforms Heavy Metals: ≤10ppm Conforms Total Plate Counts: ≤100CFU/G Conforms Purity: ≥50.0% 52% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0373 Nebivolol CAS Number: 99200-09-6 Nebivolo Appearance: White or off white Crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Specific rotation: -1.0°-- +1.0° -0.60° Loss on drying: ≤0.8% 0.7% Assay: 98--102% 99.26% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0378 Nevirapine (NVP) CAS Number: 129618-40-2 Nevirapine Appearance: Light yellow to light brown crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Solubility: Rule of ES Conforms Heavy Metals: ≤20ppm <20ppm Melting point: 244--249℃ 244.6-245.8℃ Loss on drying: ≤2.0% 0.04% Residue on Ignition: ≤0.2％ 0.04% Moisture (K. F.): ≤2.0％ 0.05% Related Substance (HPLC): Any individual impurity: ≤0.5% 0.20% Total impurities: ≤1.0% 0.20% Assay: 98--102.0% 99.2% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0383 Nisoldipine CAS Number: 63675-72-9 Nisoldipine Appearance: Yellow crystalline powder Quality Index Standard Results Identification: Positive, UV, 237nm Conforms Melting range: 148--152℃ 149.0-150.5℃ Related substances: Enterprise Standard Conforms Chloride: ≤0.01％ <0.01% Sulfate: ≤0.1％ <0.1% Loss on drying: ≤0.5％ 0.25% Residue on ignition: ≤0.10％ 0.03% Heavy metals: ≤10ppm <10ppm Iron: ≤0.001％ <0.001% Assay (C20H24N2O6): ≥98.5% 100.1% Conclusion: The Specification conforms the Enterprise Standard.
ZXFPC0387 Norcantharidinum Norcantharidinum Appearance: White crystalline powder Quality Index Standard Results Identification: Show anode Conforms Melting point: 113--116℃ 113.0-113.5℃ Residue on ignition: ≤0.1％ 0.04% Loss on drying: ≤1.0％ 0.08% Heavy metals: ≤0.001% <0.001% Assay: ≥98.5% 99.87% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0392 Olmesartan CAS Number: 144689-63-4 Olmesartan Appearance: White or off-white solid Quality Index Standard Results Identification: Rule of ES Conforms Water: ≤0.5％ 0.1% Residue: ≤0.5％ 0.1% Loss on drying: ≤0.5% 0.2% Maximum individual impurity:≤1.0% 0.19% Assay: 98--102.0% 99.2% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0397 Ondansetron HCl CAS Number: 103639-04 / Base 116002-70-1 Ondansetron HCl Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of USP28 Conforms Chromatographic purity: Compound D: ≤0.1％ Conforms Individual: ≤0.2％ Conforms Total: ≤0.5％ 0.38% Water: 9.0-10.5% 10.2% Residue on ignition: ≤0.1％ 0.05% Assay: 98.0-102.0% 99.4% Conclusion: The specification conforms to the rule of USP28.	ZXFPC0400 Oxaliplatin CAS Number: 61825-94-3 Oxaliplatin Appearance: White to almost white crystalline powder Quality Index Standard Results Identification: Rule of EP2002 Conforms Solubility: Rule of EP2002 Conforms Appearance of solution: Clear and colourless Conforms Acidity: Rule of EP2002 Conforms Specific rotation: +74.5?--+78.0? +76.5? Related substances: Single: ≤0.1% <0.1% Total: ≤0.3% <0.3% Impurity D: ≤0.1% <0.1% Silver: ≤5ppm <5ppm Loss on drying: ≤0.5％ 0.24% Bacterial endotoxins: 1.0IU/mg Conforms Assay (HPLC): 98.0-102.0% 99.71% Conclusion: The Specification conforms to the rule of EP2002.
ZXFPC0409 Pamidronate Disodium CAS Number: 109552-15-0 Pamidronate Disodium Appearance: White crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms PH: 7.5-8.5 7.8 Loss on drying: 23.0-25.0%％ 23.5% Heavy metals: ≤10ppm <10ppm Phosphorous: ≤0.5％ 0.21% Residual Solution: ≤1500ppm Conforms Assay: 98.5-101.0% 99.1% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0412 Paromomycin Sulfate CAS Number: 1263-89-4 Paromomycin Sulfate Identification: Rule of USP25 Conforms Specific rotation: +50°-- +55° +53.0° PH: 5.0-7.0 6.1 Loss on drying: ≤5.0％ 4.0% Residue on ignition: ≤2.0％ 0.29% Dentisty: 0.25-0.65g/ml 0.46g/ml Sieve Test: ≥85% (USS40) 100% Assay on drying basis: ≥675u/mg 699u/mg Conclusion: The Specification conforms to the rule of USP25.
ZXFPC0415 Pemirolast Potassium CAS Number: 100299-08-9 Pemirolast Potassium Appearance: Citron yellow crystals powder Quality Index Standard Results Identification: Rule of ES Conforms Loss on drying: ≤1.0% 0.36% Assay: 98.0---102.0% 99.69% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0419 Phentolamine Mesilate CAS Number: Base 50-60-2 Phentolamine Mesylate Appearance: White crystalline powder Quality Index Standard Results Identification: Positive Complies Melting point: 176.0--181.0℃ 178.5-181.0℃ Loss on drying: ≤0.5％ 0.11% Ignition Residue: ≤0.1% 0.06% Acid / Alkalinity: 0.05ml Max Complies Cholride: No turbidity or precipitate is produced Complies Assay: ≥99.0% 99.1%
ZXFPC0420 Phenylephrine Hydrochloride CAS Number: 61-76-7 PHENYLEPHRINE HYDROCHLORIDE Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of USP27 Conforms Solubility: Rule of ES Conforms Melting point: 140--145℃ 141--143℃ Specific rotation: -42?-- -47.5? -44.0? Loss on drying: ≤1.0% 0.06% Residue on Ignition: ≤0.2％ 0.04% Sulfate: ≤0.2％ Conforms Limit of Ketones: Not deeper than control solution Conforms Chromatographic purity: Single ≤0.5％ Conforms Chloride Content: 17.0-17.7% 17.5% Assay: 97.5-102.5% 99.3% Conclusion: The Specification conforms to the rule of USP27.	ZXFPC0425 Pioglitazone HCl CAS Number: 111025-46-8 Pioglitazone (HCl) Appearance: White to off-white crystalline powder Quality Index Standard Results Identification Enterprise Standard Conforms Solubility: Enterprise Standard Conforms Melting range: 190--194℃ 190.4-192.9℃ Loss on drying: ≤0.5％ 0.18% Residue on ignition: ≤0.1％ <0.1% Heavy metals: ≤10ppm <10ppm Water: ≤0.5% 0.15% Organic Volatile Impurities: Enterprise Standard Conforms Single impurity: ≤0.5% <0.5% Total impurities: ≤1.0% <1.0% Assay (by HPLC): ≥99.0% 99.37% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0428 Pirfenidone CAS Number: 53179-13-8 Pirfenidone Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Melting point: 106--108℃ 106.2-108.0℃ Loss on drying: ≤0.5% 0.42% Assay: 97.0-102.0% 98.2% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0432 Podophyllotoxin CAS Number: 4354-76-1 Podophyllotoxin Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Melting point: 182--187℃ 183℃ Specific rotation: -131?-- -134? -132? Related substances: ≤2.0% Conforms Loss on drying: ≤2.0% 1.1% Residue on ignition: ≤0.1% 0.07% Heavy metals: ≤20ppm <10ppm Assay: ≥93.0% 94.6% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0441 Pravastatin Sodium CAS Number: 81093-37-0 Pravastatin Sodium Appearance: White crystalline powder Quality Index Standard Results Identification: IR, Na+Test Conforms Appearance of Solution: Clear Clear Color of Solution: ≤BY6 Conforms PH: 7.2-9.0 7.5 Specific rotation: +153°-- +159° +156° Related substance: 6'-epipravastatin Sodium: ≤0.3％ 0.01% Pravastatin Lactone: ≤0.2％ 0.00% Any other impurity: ≤0.1％ 0.01% Total Impurities: ≤0.6％ 0.02% Residual Solvents: Ethanol: ≤3.0％ 1.6% Ethyl Acetate: ≤0.5％ 0.2% Heavy metals: ≤20ppm <20ppm Water (KF): ≤4.0％ 1.0% Assay: 98.0-102.0% 100.2% Conclusion: The Specification conforms to the Enterprise Standard / Ph.Eur. 4.3.	ZXFPC0445 Proglumide CAS Number: 6620-60-6 Proglumide Appearance: White crystalline powder Quality Index Standard Results Identification: Rule of CP2005 Conforms Melting range: 148.5--152℃ 149.0-150.5℃ Chloride: Rule of CP2005 Conforms Loss on drying: ≤0.5％ 0.1% Residue on ignition: ≤0.1％ 0.04% Heavy metals: ≤10ppm <10ppm Assay: ≥99.0% 99.6% Conclusion: The Specification conforms to the rule of CP2005.
ZXFPC0448 Prulifloxacin CAS Number: 123447-62-1 Prulifloxacin Appearance: Yellow crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Appearance of solution: Rule of ES Conforms Fluorin content: 3.5-5.0% 3.82% Loss on drying: ≤1.0% 0.38% Residue on Ignition: ≤0.2％ 0.07% Heavy Metals: ≤20ppm <20ppm Related Substance: ≤1.0% 0.53% Acetonitrile: ≤0.041% 0.012% Dioxane: ≤0.038% 0.008% Carbon Tetrachloride: ≤0.0004% N. D. Assay: >98.5% 99.47% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0451 Rabeprazole CAS Number: 117976-89-3 Rabeprazole (Sodium) Appearance: Off-white to pale yellowish crystalline powder, Hygroscopic Quality Index Standard Results Identification: Rule of ES Conforms Solubility: Rule of ES Conforms Water (K.F.): ≤7.0% 1.6% Heavy metals: ≤20ppm <20ppm Related substances: Individual impurity: ≤0.3% 0.21% Total impurity: ≤1.5% 0.73% Assay: 99.0---101.0% 99.51% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0457 Ramipril CAS Number: 87333-19-5 Ramipril Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of EPIV Conforms Melting point: 107--110℃ 107.5-108.0℃ Specific rotation: +32?--+38? +34.4? Loss on drying: ≤0.2% 0.04% Residue on Ignition: ≤0.1% 0.04% Heavy Metals: ≤20ppm Conforms Related substances: Impurity A,B,C,D: ≤0.5% <0.5% Individual: ≤0.1% <0.1% Total: ≤1.0% 0.27% Residue Solvent: Rule of EPIV Conforms Assay(HPLC): 98.0-101% 99.88% Conclusion: The Specification conforms to the rule of EPIV.	ZXFPC0460 Rapamycin / Sirolimus CAS Number: 53123-88-9 Rapamycin Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Related substances: Tautomer: ≤3.0% 2.0% Individual: ≤1.0% 0.5% Total: ≤3.0% 1.0% Water (K.F.): ≤1.0％ 0.4% Residue on ignition: ≤0.5％ 0.03% Heavy metals: ≤20ppm <20ppm Assay (Based on dried): >96% 99.1% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0462 Reserpine CAS Number: 50-55-5 Reserpine Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Rule of CP2000 Conforms Specific rotation: -115°-- -131° -121.6° Loss on drying: ≤0.5% 0.42% Residue on Ignition: ≤0.15％ 0.09% Related Substance: Rule of CP2000 Conforms Assay: 97.0-103.0% 99.52% Conclusion: The Specification conforms to the rule of CP2000.	ZXFPC0467 Rifabutin CAS Number: 72559-06-9 Rifabutin Appearance: A red-violet powder Quality Index Standard Results Identification: Rule of USP24 Conforms Loss on drying: ≤2.5% 1.8% Limit of N-Iso Butylpiperidone: ≤0.5% Conforms Chromatopraphic Purity: Individual impurity: ≤1.0% Conforms Total impurities: ≤3.0% 1.7% Assay: 98--102.0% 98.6% Conclusion: The Specification conforms to the rule of USP24.
Rifampicin CAS Number: 14487-05-9 Rifampicin Appearance: A brick-red to reddish brown crystalline powder Quality Index Standard Results Identification: Rule of BP2004 Conforms Bulk Density: 0.7--0.75g/ml 0.74g/ml PH: 4.5-6.5 5.6 Loss on drying: ≤1.0％ 0.54% Sulphated Ash: ≤0.1% 0.06% Heavy metals: ≤20ppm <20ppm Related substances: Rifampicin Quinone ≤1.5％ <1.5% One Peak ≤1.0％ <1.0% Sum of Peaks ≤3.5％ <3.5% Assay (On dry basis): 97.0-102.0% 99.8% Conclusion: The Specification conforms to the rule of BP2004.	ZXFPC0472 Risedronate Sodium CAS Number: 115436-72-1 Risedronate Sodium Appearance: White crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms PH: 4.0-5.0 4.32 Chloride: ≤0.005％ <0.005 Sulfate: ≤0.005％ <0.005% Related substances: ≤1.0％ 0.31% Loss on drying: 11.6-13.5％ 12.58% Phosphate: ≤0.4％ 0.034% Heavy metals: ≤10ppm <10ppm Chlorobenzene: ≤0.005％ <0.005 Assay: 98.0-101.0% 99.7% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0478 Rofecoxib CAS Number: 162011-90-7 Rofecoxib Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Heavy Metals: ≤20ppm <20ppm Residue on Ignition: ≤0.1％ 0.05% Loss on drying: ≤0.5% 0.12% Assay: 98.0-102.0% 99.53% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0479 Ropinirole HCl CAS Number: 91374-21-9 Ropinirole Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Melting point: 243-244.5℃ 243-244.5℃ Loss on drying: ≤0.5% 0.42% Assay: 97--103.0% 98.3% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0480 Rosiglitazone Base / HCl / Maleate CAS Number: 122320-73-4 Rosiglitazone HCl Appearance: Off-white to white crystalline powder Quality Index Standard Results Identification: Rule of Enterprise Standard Conforms Loss on drying: ≤7.0％ 6.50% Residue on ignition: ≤0.1％ 0.03% Heavy metals: ≤10ppm <10ppm Single impurity: ≤0.5％ 0.18% Total impurities: ≤1.0％ 0.45% Assay: ≥99% 99.55% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0484 Rubitecan CAS Number: 91421-42-0 Rubitecan Appearance: Yellow powder Quality Index Standard Results Identification: Rule of ES Conforms Related Substance: ≤1.0% 0.54% Limit of Trichloromethane: ≤0.006％ 0.0017% Loss on drying: ≤0.5% 0.14% Assay: 98--102.0% 99.4% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0488 Sarpogrelate HCl CAS Number: 125926-17-2 SARPOGRELATE HYDROCHLORIDE Analysis Standard Result Appearance White to off white crystalline powder Complies Solubility Sparingly soluble in ethanol, acetone, water Complies Identification Melting point: 139-142℃ IR H1NMR 140.2-141.5℃ Complies Complies Loss on drying 1% max 0.15% Residue on ignition 0.2% max 0.06% Heavy metals 20ppm max Complies Related substance Single impurity: 1.0% max Total impurities: 2.0% max 0.47% 0.68% Assay 98.0% min 99.1% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0495 Simvastatin CAS Number: 79902-63-9 Simvastatin Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Positive Conforms Specific rotation: +285°-- +298° +292° Loss on drying: ≤0.5％ 0.06% Residue on ignition: ≤0.10％ 0.02% Heavy metals: ≤0.002% <0.002% Lovastatin: ≤1.0％ 0.1% Chromatographic purity: Major: ≤0.4％ Conforms Total: ≤1.0％ Conforms Assay: 98.0-101.0% 99.3% Conclusion: The Specification conforms to the rule of USP24.
ZXFPC0497 Sisomicin Sulfate CAS Number: 32385-11-8 Sisomicin Sulfate Appearance: White and almost white crystalline powder Quality Index Standard Results Identification: Positive Positive PH: 3.5-5.5 4.3 Specific rotation: +100?-- +110? +101? Loss on drying: ≤15.0% 10.3% Sulphated Ash: ≤1.0％ 0.15% Assay: ≥580U/mg 612U/mg Conclusion: The Specification conforms to the rule of USP26.	ZXFPC0502 Sodium Hyaluronate CAS Number: 9067-32-7 Sodium Hyaluronate Appearance: White odorless powder Quality Index Standard Results Identification: Rule of ES Conforms PH(1g/L solution): 6.0-7.5 6.89 Glucuronic Acid: ≥43% 44.2% Molecular weight: ≥1.2106 1.6106 Proteins (TCA): ≤0.1% 0.08% Loss on drying: ≤8% 6.12% Heavy metals: ≤20ppm <20ppm Arsenic: ≤2ppm <2ppm Total plate count: ≤10/g Conforms Sulphated Ash: ≤0.1% 0.07% Assay(Sodium Hyaluronate): ≥90% 95.26% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0509 Stavudine (D4T) CAS Number: 3056-17-5 Stavudine Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Positive reaction Conforms Melting point: 160--166℃ 162.6℃ Specific rotation: -41?-- -46? -41.6? Residue on ignition: ≤0.15% 0.02% Total of impurity(HPLC): ≤1.0% 0.29% Loss on drying: ≤1.0% 0.23% Heavy metals: ≤10ppm <10ppm Assay: 98.5---101.0% 99.71% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0512 Sumatriptan Succinate CAS Number: Base 103628-46-2 Sumatriptan Succinate Appearance: Off-white and yellowish powder Quality Index Standard Results Identification: Rule of ES Conforms Solubility: Rule of ES Conforms PH: 4.3-5.3 4.8 Loss on drying: ≤0.5% 0.2% Melting point: 165--170℃ 166--168℃ Heavy metals: ≤20ppm <20ppm Residue on Ignition: ≤0.1% 0.03% Related Impurities: ≤1.0% 0.15% Assay: 98--101% 99.85% Conclusion: The Specification conforms to the rule of Enterprise Standard
ZXFPC0514 Tacrolimus CAS Number: 104987-11-3 Tacrolimus Appearance: White crystalline powder Quality Index Standard Results Identification: Positive Conforms Water: ≤3.0％ 2.4% Heavy Metals: ≤20ppm <20ppm Related Substance: ≤5.0% Conforms Assay: 95% Min 98.1% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0519 Tegafur CAS Number: 17902-23-7 Tegafur Appearance: White or almost white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Aspect of Solution: Clear Conforms Melting point: 164---169℃ 166--167℃ Heavy metals: ≤20ppm <20ppm Related substances: Rule of ES Conforms Chloride: ≤0.2% Conforms Loss on drying: ≤0.5% Conforms Assay: 98.0---102.0% 99.49% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0524 Temozolomide CAS Number: 85622-93-1 Temozolomide Appearance: Similar white to light red crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Loss on drying: ≤1.0% 0.4% Heavy metals: ≤20ppm <20ppm Residue on ignition: ≤0.1% 0.08% Chloride: ≤0.02% <0.02% Related substances: Rule of ES Conforms Assay: 98.5---102.0% 99.31% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0528 Terbinafine HCl CAS Number: 78628-80-5 Terbinafine HCl Appearance: White or off-white powder Quality Index Standard Results Particle Size: ≤100um Conforms Melting point: 204--208℃ 205.9-207.1℃ PH: 3.0-4.5 4.01 Related substances: ≤1.0％ 0.37% Loss on drying: ≤0.5％ 0.14% Residue on Ignition: ≤0.1％ 0.02% Heavy metals: ≤20ppm <20ppm Assay: ≥98.5% 99.35% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0529 Tetrandrine CAS Number: 518-34-3 Tetrandrine Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Positive Conforms Melting point: 216--221℃ 219℃ Other Alkaloid: ≤8.0% 2.9% Content of Benzene: ≤0.0002% <0.0002% Loss on drying: ≤1.0% 0.68% Residue on Ignition: ≤0.1％ 0.06% Heavy Metals: ≤10ppm <10ppm Assay: 97.0-103.0% 98.67 Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0532 Tiagabine CAS Number: 145821-59-6 / 115103-54-3 Tiagabine Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Specific rotation: -9.8?-- -10.8? -10.5? Melting point: 189--196℃ 190.4-194.5℃ Acetone: ≤5000ppm <50ppm Water ( by K. F.): ≤6.0％ <0.20% Residue on Ignition: ≤0.2％ <0.03% Heavy Metals: ≤20ppm <20ppm Assay: >99% 99.6% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0541 Tobramycin Sulphate CAS Number: 49842-07-1 / Base 32986-56-4 Tobramycin Sulphate Quality Index Standard Results Identification: Rule of USP26 Conforms PH: 6.0-8.0 7.73 Water: ≤2.0% 0.82% Residue on Ignition: ≤1.0％ 0.07% Heavy Metals: ≤0.003% <0.003% Chromatographic purity: ≤1.0% Conforms Bacterial endotoxins: ≤2.00EU/mg Conforms Assay: 634-739ug/mg 657ug/mg Conclusion: The Specification conforms to the rule of USP26.	ZXFPC0542 Tolterodine Tartrate CAS Number: 124937-52-6 Tolterodine (Tartrate) Appearance: White or off-white crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Melting point: 204--208℃ 206.0-207.0℃ Specific rotation: +28°-- +30° +28° Related substances: ≤1.0％ Conforms PH: 3.0-4.5 3.6 Loss on drying: ≤0.5％ 0.04% Residue on ignition: ≤0.1％ 0.08% Heavy metals: ≤20ppm <20ppm Assay: ≥98.5% 99.4% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0544 Topotecan Hydrochloride CAS Number: 119413-54-6 Topotecan Hydrochloride Appearance: Pale yellow-green crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms PH: 3.0-5.0 3.5 Clarity and colour of solution: Rule of ES Conforms Related substances: ≤1.0％ Conforms Chloride content: 7.4-8.5％ 8.1% Loss on drying: ≤3.0％ 1.4% Residue on ignition: ≤0.5％ 0.2% Heavy metals: ≤10ppm Conforms Specific rotation: +91°-- +101° +94.2° Assay(by HPLC): ≥99.0% 99.25% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0547 Tranilast CAS Number: 53902-12-8 Tranilast Appearance: Light yellow green crystalline powder Quality Index Standard Results Loss on drying: ≤0.5％ 0.12% Melting point: 207--211℃ 207.9-208.8℃ Residue on Ignition: ≤0.15％ 0.09% Heavy metals: ≤15ppm <15ppm Chloride: ≤0.01% <0.01% Assay: ≥98.5% 99.25% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0549 Tretinoin(Retinoic acid) CAS Number: 302-79-4 Tretinoin Appearance: Yellow to Light-yellow crystalline powder Quality Index Standard Results Identification: Rule of USP24 Conforms Loss on drying: ≤0.5% 0.28% Residue on Ignition: ≤0.1％ 0.07% Heavy Metals: ≤20ppm <20ppm Isotretinoin: ≤5.0％ <5.0% Assay: 98--102.0% 99.3% Conclusion: The Specification conforms to the rule of USP24.	ZXFPC0558 Trypsin CAS Number: 9002-07-7 Trypsin Appearance: White crystalline powder Quality Index Standard Results Identification: BP98 Conforms PH: 5.0-7.0 5.75 Clarity and Colour of Solution: BP98 Conform Chymotrypsin: ≤5.0% 5.0% Loss on drying: ≤5.0% 4.2% Residue on Ignition: ≤2.5% 2.1% Assay: ≥2500u/mg 4000u/mg Conclusion: The Specification conforms the rule of BP98.
ZXFPC0568 Ursolic acid CAS Number: 77-52-1 Ursolic acid Appearance: White powder Quality Index Standard Results Identification: Rule of ES Conforms Moisture: ≤5% 1.48% Pesticides: Negative Conforms Heavy Metal: <10ppm Conforms Total of Bacteria: <1000/g Conforms Fungi: <100/g Conforms Salmonella: Negative Conforms Coli: Negative Conforms Assay: ≥95.0％ 95.25% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0571 Valsartan CAS Number: 137862-53-4 Valsartan Appearance: White or yellowish crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms Specific rotation: -60.0?-- -67.0? -64.2? Related Substance: ≤2.0% Conforms Chiral isomer: ≤2.0% Conforms Loss on drying: ≤2.0% 0.6% Residue on Ignition: ≤0.1％ 0.09% Heavy Metals: ≤10ppm <10ppm Assay: 98--102.0% 99.5% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0578 Vinorelbine Tartrare Vinorelbine Tartrate Appearance: White powder Quality Index Standard Results Identification: Rule of ES Conforms Solubility: Easily soluble in Water Conforms Clarity of solution: Clear solution Conforms Color of solution: ≤0.03% (420nm, 1%water) 0.009% Water: ≤4.0% 2.7% Residue on ignition: ≤0.1% 0.07% PH: 3.3-3.8 (10mg/ml) 3.62 Related substances: ≤0.7% Conforms Chromatographic Purity HPLC: 99% Min 99.66% Assay: 98.0---102.0% 101.2% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0579 Vinpocetin CAS Number: 42971-09-5 Vinpocetine Appearance: White crystalline powder Quality Index Standard Results Identification: Rule of Enterprise Standard Conforms Moisture: ≤0.5％ 0.1% Ash: ≤0.1％ 0.01% Specific rotation(D-021/2): +129°-- +133° Conforms Total Plate Count (USP)-Colonies/g:≤10000 <100 Coliform (Petrifilm) -Colonies/g:≤10 <10 E. Coli (Petrifilm) -Colonies/g: Negative Negative Salmonella (AOAC) -Colonies/g: Negative in 25g Negative Heavy metals(USP): ≤10ppm <10ppm Assay (HPLC): ≥99.0% 99.6% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0580 Vitamin B12 CAS Number: 68-19-9 Vitamin B12 (Cyanocobalamin) Appearance: Dark red crystalline powder Quality Index Standard Results Identification: Positive Positive Loss on drying: ≤12％ 2.87% Pseudo Cyanocobalamin: Rule of USP24 Conforms Pyrogen: Rule of USP24 Conforms Assay: 96.0-100.5% 98.44% Conclusion: The Specification conforms to the rule of USP24.	ZXFPC0581 Vitamin D2 Medical Grade CAS Number: 67-97-0 Vitamin D2 (Ergocalciferol) Appearance: A white crystalline powder Quality Index Standard Results Identification: Rule of BP98/USP24 Conforms Melting point: USP24 115.0-119.0℃ 115.1-116.8℃ BP98 112.0-117.0℃ 112.2-114.9℃ Specific rotation: +103.0°-- +107.0° +104.0° Light absorption: BP98 450-500 470 Organic volatile impurities: Benzene <100ppm None Solubility: Freely soluble in alcohol Conforms Reducing substances: <20ppm Conforms Ergosterol: None Conforms Assay (by HPLC) 40MIU/G: 97--103% 99.3% Conclusion: The Specification conforms to the rule of BP98/USP24.
ZXFPC0583 Voglibose CAS Number: 83480-29-9 Voglibose Appearance: White crystalline powder Quality Index Standard Results Identification: Rule of ES Conforms PH: 9.2-10.2 10.0 Melting point: 163--168℃ 165.0℃ Clarity and color of solution: Clear and colorless Conforms Specific rotation: +45?--+48? +46.0? Loss on drying: ≤0.5% 0.26% Heavy Metals: ≤10ppm Conforms Residue on Ignition: ≤0.1% 0.06% Total impurities: ≤2.0% 0.50% Assay(HPLC on dried base): ≥98.5％ 99.6% Conclusion: The Specification conforms to the rule of Enterprise Standard.	ZXFPC0584 Voriconazole CAS Number: 137234-62-9 Voriconazole Appearance: White powder Quality Index Standard Results Identification: Rule of ES Conforms Related Substance : ≤0.5% 0.42% Optical Isomers: ≤0.5％ 0.11% Loss on drying: ≤0.5% 0.30% Heavy Metals: ≤20ppm <20ppm Assay: >99.0% 99.56% Conclusion: The Specification conforms to the rule of Enterprise Standard.
ZXFPC0589 Zidovudine (AZT) CAS Number: 30516-87-1 Zidovudine (AZT) Appearance: White to yellowish crystalline powder Quality Index Standard Results Identification: IR and HPLC Conforms Solubility: Rule of USP27 Conforms Specific rotation: +60.5°-- +63.0° +62.25° Water: ≤1％ 0.1% Residue on Ignition: ≤0.25％ 0.06% Related Substances (HPLC): Thymine: ≤2.0％ 0.02% Impurity B: ≤1.0％ Conforms Total impurities: ≤3.0％ 0.05% Residual Solvents: Rule of USP27 Conforms Assay: 97--102% 99.7% Conclusion: The Specification conforms to the rule of USP27.	ZXFPC0592 Zoledronic Acid CAS Number: 118072-93-8 Zoledronic Acid Appearance: White crystalline powder Quality Index Standard Results Identification: IR Conforms Related substances: ≤1.0％ 0.36% Single Impurity: ≤0.5％ 0.19% Limit of Dichloromethane: ≤0.06％ 0.003% Limit of Ethylacetate: ≤0.05％ 0.002% Acid Value: 1.5-2.5 1.9 Loss on drying: 5.9-7.0% 6.4% Heavy metals: ≤10ppm <10ppm Assay: ≥98.5% 99.2% Microbiological: Total plat count: ≤1000CFU/gm Conforms Yeast & Mold: ≤100CFU/gm Conforms Salmonella: Negative Negative E. Coli: Negative Negative Conclusion: The Specification conforms to the rule of Enterprise Standard.

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