Description

Mupirocin Calcium, Reference Spectrum EP Standard is a high-purity certified reference material (CRM) used for analytical quality control and method validation. This compound is critical for ensuring the accuracy and reliability of pharmaceutical testing, particularly for the antibiotic Mupirocin. It is essential for laboratories in the pharmaceutical, regulatory, and contract research sectors that require traceable and verifiable standards for compliance with European Pharmacopoeia (EP) monographs.

Application

• Primary Standard for Pharmacopoeial Compliance: Used as a reference standard for the identification, assay, and impurity testing of Mupirocin and Mupirocin Calcium in accordance with European Pharmacopoeia (EP) and other international pharmacopoeial methods.

• HPLC and UPLC Method Development & Validation: Serves as a critical component for developing, calibrating, and validating chromatographic methods to ensure specificity, accuracy, and precision.

• Quality Control in Pharmaceutical Manufacturing: Employed in in-process testing and release testing of bulk active pharmaceutical ingredients (APIs) and finished dosage forms to verify identity, potency, and purity.

• Spectroscopic Analysis: Provides a certified reference spectrum for techniques such as Infrared (IR) spectroscopy and Nuclear Magnetic Resonance (NMR) for definitive compound identification.

• Regulatory Submissions and Audits: Supports regulatory filings (e.g., with EMA, FDA) and internal quality audits by providing documented evidence of testing with a qualified reference material.

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  | Product Name | Mupirocin Calcium, Reference Spectrum EP Standard |
  | CAS No. | 115074-43-6 |
  | Molecular Formula | C52H86CaO18 |
  | Molecular Weight | 1039.31 g/mol |
  | Synonyms | Pseudomonic Acid Calcium Salt; Bactroban Calcium Salt; (2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic Acid, Ester with 9-Hydroxynonanoic Acid, Calcium Salt; Calcium Mupirocin; Mupirocin Calcium Salt; Antibiotic BRL 4910A Calcium Salt; MUP-CA |
  | EINECS | Contact for details |

  Quality Control

  This Reference Spectrum EP Standard is manufactured and certified under strict quality management systems. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that provides traceability to primary standards and includes data for identity, purity (assay), and specified impurities as per relevant pharmacopoeial guidelines. Our quality control protocols ensure compliance with the requirements for chemical reference substances as outlined in the European Pharmacopoeia.

  Storage

  Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and certified potency. Return the container to storage immediately after use.

  Specification

  Item	Specification
  Appearance	White to off-white powder
  Identification (IR)	Conforms to Reference Spectrum
  Identification (HPLC)	Retention time corresponds to reference standard
  Assay (HPLC)	≥ 98.0% (on anhydrous basis)
  Water Content (KF)	≤ 5.0%
  Related Substances (HPLC)	Complies with EP limits
  Heavy Metals	≤ 20 ppm
  Residual Solvents	Complies with ICH Q3C

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