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Hydrocodone Bitartrate

Hydrocodone Bitartrate is a potent Active Pharmaceutical Ingredient (API) in the therapeutic category of pain management and antitussive agents, synthesized and purified at Parand Darou Pharmaceutical Company in compliance with the most reputable international pharmacopeial standards, including the British Pharmacopoeia (BP) and United States Pharmacopeia (USP).

Quality Standards & Specifications

This compound features a high purity level of at least 99.0% and an assay range of 99.0% to 101.0% on an anhydrous basis. Strict control of physicochemical parameters, including acidity (pH 3.2 to 3.8), water content (7.0% to 12.0%), and specific optical rotation (-87° to -91°), ensures optimal efficacy, bioavailability, and safety for pharmaceutical product manufacturing.

Physical Properties & Storage Conditions

Hydrocodone Bitartrate is supplied as a white or almost white, hygroscopic crystalline powder that is freely soluble or soluble in water. Due to its sensitivity to humidity and light, storage in airtight containers protected from direct light is mandatory to maintain its stability for at least two years at room temperature.



General Information

Product Name Hydrocodone Bitartrate
Chemical Name 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one hydrogen (2R,3R)-2,3-dihydroxybutanedioate 2.5-hydrate
Manufacturer Parand Darou Co.
CAS No. 34195-34-1
Category Pain management
Pharmacopoeia BP, USP

Specification

Molecular formula

Specification

Molecular formula C18H21NO3 · C4H6O6 · 2½ H2O 494.5 pH 3.2 to 3.8
Appearance White or almost white, hygroscopic, crystalline powder Purity Min. 99.0%
Solubility Freely soluble or soluble in water, sparingly soluble in ethanol (96%), practically insoluble in cyclohexane Assay 99.0% to 101.0% (anhydrous)
Water 7.0% to 12.0% Storage Airtight container; protected from light
Specific rotation -87° to -91° (anhydrous) Stability Stable at least 2 years at R.T
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Active Pharmaceutical Ingredient (API)

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