ZXFPC0283 Irinotecan HCl Trihydrate

CAS Number: 100286-90-6

Irinotecan HCl (trihydrate)

Appearance: Pale yellow powder

Quality Index Standard Results

Identification: A. IR and B. HPLC Conforms
Solubility: Rule of ES Conforms
PH: 3.0-5.0 4.6
Absorbance at 430nm: ≤0.7 Conforms
Water: 7.0-9.0% 8.2%
Chloride: 3.0-5.5％ Conforms
Specific rotation [α]D20: +60°-- +73° +65°
Residue on ignition: ≤0.1％ 0.08%
Heavy metals: ≤20ppm <20ppm
Related Substance (HPLC):
Total: ≤1.0％ 0.48%
Individual: ≤0.5％ 0.17%
Purity by HPLC: >99.0% 99.52%
Assay (HPLC): 99.0-101.0% 99.79%

Conclusion: The Specification conforms to the rule of Enterprise Standard.

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