Globela Pharma Pvt Ltd sell "Advance Intermediate and API"
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Service Name
Advance Intermediate and API
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Specifications
- Purity: Assay ≥98.0% on a dry basis by HPLC (or as per compendial monograph), consistent with pharmaceutical/technical-grade specification.
- Loss on Drying: Loss on drying ≤0.5% w/w, determined per compendial method (e.g., USP <731> / Ph. Eur. 2.2.32).
- Residual Solvents: Residual solvents controlled within ICH Q3C limits for the relevant solvent class.
- Impurity Profile: Any single unspecified impurity ≤0.10%; total impurities ≤0.50%, consistent with ICH Q3A/B guidance.
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