Pristinamycin IA API Manufacturer in India

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Pristinamycin IA API Manufacturer in India

Pristinamycin IA is a naturally derived streptogramin B antibiotic and an individual component of the pristinamycin antibiotic complex. It is also known as Mikamycin B, Mikamycin IA, Ostreogrycin B, Vernamycin Bα and Virginiamycin B. Pristinamycin IA is produced naturally by microorganisms including Streptomyces pristinaespiralis.

Pristinamycin IA has the CAS Number 3131-03-1, molecular formula C₄₅H₅₄N₈O₁₀, and molecular weight approximately 866.96–867.0 g/mol. PubChem identifies it as a cyclodepsipeptide/peptidic macrolactone antibiotic and confirms its identity as Pristinamycin IA.

Unlike the overall Pristinamycin complex, which contains multiple streptogramin components, Pristinamycin IA represents the streptogramin B component and should therefore be specified and documented separately when used as an individual API or reference material.

Pristinamycin IA API

Pristinamycin IA API is a complex cyclic peptide antibiotic belonging to the streptogramin B family. It is a structurally complex natural product with multiple stereocenters and peptide-like cyclic architecture.

Commercial analytical sources describe Pristinamycin IA as a crystalline solid. Research-grade material is available with high chromatographic purity, including products reported at ≥98% HPLC and specific analytical standards reported at 99.98% assay/purity. These values are commercial/reference-material specifications and should not be represented as a universal pharmacopoeial API limit.

Because of its complex molecular structure, quality assessment is better based on chromatographic and spectrometric identity and purity methods rather than conventional small-molecule tests alone.

Chemical and Pharmaceutical Profile

Chemical Name: Pristinamycin IA
CAS Number: 3131-03-1
Molecular Formula: C₄₅H₅₄N₈O₁₀
Molecular Weight: 866.96 g/mol
UNII: V50XJ0NC3I
ChEBI: CHEBI:8417
Synonyms: Mikamycin B, Mikamycin IA, Ostreogrycin B, Vernamycin Bα, Virginiamycin B
API Type: Natural-Product / Cyclic Peptide Antibiotic
Antibiotic Class: Streptogramin B
Physical Form: Crystalline solid

PubChem reports a molecular weight of approximately 867.0 g/mol and identifies Pristinamycin IA as a cyclodepsipeptide antibiotic and component of pristinamycin.

Pharmaceutical Applications

Pristinamycin IA is a component of the pristinamycin antibiotic system and belongs to the streptogramin B group. Pristinamycin contains complementary streptogramin components that act synergistically against susceptible Gram-positive bacteria.

Pristinamycin IA may be relevant to:

  • Streptogramin antibiotic research
  • Antibacterial pharmaceutical research
  • Pristinamycin component analysis
  • Microbiological and antimicrobial research
  • Pharmaceutical analytical development
  • Reference-standard development
  • Natural-product antibiotic research

Pristinamycin itself has been used primarily against susceptible staphylococcal and streptococcal infections, while Pristinamycin IA is one of its individual active components.

Quality and Analytical Testing

Pristinamycin IA is a structurally complex natural-product antibiotic, so analytical characterization should use multiple complementary techniques.

Relevant analytical testing may include:

  • HPLC assay
  • HPLC related-substance analysis
  • LC-MS / LC-MS/MS
  • High-resolution mass spectrometry
  • IR spectroscopy
  • H-NMR and C-NMR
  • Optical rotation where applicable
  • Water determination
  • Loss on drying
  • Residue/sulfated ash
  • Elemental impurity testing where applicable

A commercial reference specification for Pristinamycin IA reports assay 99.0–101.0% on anhydrous substance, loss on drying NMT 2.0%, water NMT 1.0%, heavy metals NMT 10 ppm, residue on ignition NMT 0.1%, individual unspecified impurity NMT 0.10% and total impurities NMT 0.5%. These are identified as a commercial reference specification, not a USP/BP/Ph. Eur. universal monograph.

Other commercial reference materials report ≥98% purity, while one Pristinamycin IA analytical standard reports 99.98% purity/assay and 99.98% ee.

Pristinamycin IA API Manufacturer in India

Pristinamycin IA is a complex natural-product antibiotic requiring specialized manufacturing, purification and analytical characterization. Because the molecule contains multiple stereochemical centers and a complex cyclic peptide structure, manufacturing controls should focus on consistent fermentation or production inputs, purification efficiency, degradation control and chromatographic purity.

A suitable pharmaceutical-quality analytical program should use orthogonal identity techniques such as HPLC, LC-MS and spectroscopic characterization. Where applicable, stereochemical purity and related substances should also be controlled.

Pristinamycin IA should be released against a documented specification appropriate to the intended pharmaceutical, analytical or research application.

Packaging and Storage

Pristinamycin IA should be protected from moisture, light and unsuitable environmental conditions and stored in tightly closed pharmaceutical-grade containers.

Commercial reference materials report different validated storage conditions, including −20°C for certain analytical products and 4°C for other research-grade products.

Therefore, the final API storage condition should be based on validated stability data for the actual material and packaging system.

Recommended CMS wording:

Store in tightly closed, light-resistant containers under validated temperature and humidity conditions. Protect from moisture, heat and direct light.

Documentation

Pristinamycin IA API documentation may include:

  • Certificate of Analysis (CoA)
  • Certificate of Conformance (CoC)
  • Product Specification
  • Safety Data Sheet (SDS)
  • HPLC Assay Report
  • Related Substances Report
  • LC-MS / LC-MS-MS Report
  • IR Identification Report
  • NMR Characterization Report
  • Optical Rotation Data where applicable
  • Water / Loss on Drying Report
  • Residue on Ignition Report
  • Elemental Impurity Data
  • Stability Data
  • GMP Documentation where applicable
  • Technical Data Sheet
  • Batch Documentation

Documentation should correspond to the actual batch and its approved analytical specification.

Why Choose Pristinamycin IA API Manufacturer in India

Pristinamycin IA is a specialized streptogramin B antibiotic component with a highly complex cyclic peptide structure. Its quality evaluation requires more comprehensive characterization than conventional small-molecule APIs.

A quality-focused Pristinamycin IA manufacturing program should combine controlled production, efficient purification, validated chromatographic testing and orthogonal structural characterization.

Consistent control of assay, related substances, water content, identity and stereochemical characteristics can help support reliable Pristinamycin IA for pharmaceutical research, analytical applications and appropriate antibiotic development programs.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 99.0–101.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.10%
Total Impurities NMT 0.5%
Water Content NMT 1.0%
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