Description

Pilocarpine Hydrochloride Ep Impurity C is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the active pharmaceutical ingredient Pilocarpine Hydrochloride, enabling precise monitoring and quantification to ensure drug safety and efficacy. It is an essential material for analytical laboratories, quality assurance departments, and research institutions involved in method development, validation, and regulatory compliance for ophthalmic and other pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity C in Pilocarpine Hydrochloride drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or other chromatographic methods in compliance with ICH Q2(R1) and pharmacopoeial guidelines (EP, USP).
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles, ensuring batch-to-batch consistency and adherence to strict pharmacopoeial limits (e.g., European Pharmacopoeia).
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Pilocarpine Hydrochloride.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate control over the drug substance's impurity profile.
• Research & Development: Supports impurity isolation, characterization, and toxicological studies in pharmaceutical R&D.

Basic Information

Product Name	Pilocarpine Hydrochloride Ep Impurity C
CAS No.	34350-99-7
Molecular Formula	C11H16N2O2 • HCl
Molecular Weight	244.72 g/mol (Free base: 208.26 g/mol)
Synonyms	Pilocarpine Impurity C; Pilocarpine Related Compound C; (3S,4R)-3-Ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]dihydrofuran-2(3H)-one hydrochloride; Pilocarpine HCl Impurity C; EP Impurity C of Pilocarpine Hydrochloride; Pilocarpine Hydrochloride Impurity C (EP); 3-Ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-2(3H)-furanone hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Pilocarpine Hydrochloride Ep Impurity C is manufactured and analyzed under strict quality management systems. The product is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results against predefined specifications. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeias (EP, USP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.