Meclocycline API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Meclocycline API

Meclocycline is a tetracycline-class antibiotic with broad-spectrum antibacterial activity. It is primarily used in topical dermatological formulations, particularly for the management of acne and other susceptible bacterial skin conditions.

Meclocycline is commonly formulated as meclocycline sulfosalicylate, a salt form used in topical pharmaceutical products.

Meclocycline API Manufacturer in India

Meclocycline is a specialized dermatological pharmaceutical API used in the development and manufacture of topical antibacterial formulations.

Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and microbiological quality, according to the applicable API specification.

Chemical Information

CAS Number: 7381-01-3
Molecular Formula: C21H21N3O8
Molecular Weight: 443.41 g/mol
Chemical Name: Meclocycline
Common Pharmaceutical Form: Meclocycline Sulfosalicylate
Drug Class: Tetracycline Antibiotic
Therapeutic Class: Topical Antibacterial
Therapeutic Area: Dermatology
Molecule Type: Semi-Synthetic Antibiotic

Mechanism of Action

Meclocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis.

It binds primarily to the 30S ribosomal subunit of susceptible bacteria and interferes with the attachment of aminoacyl-tRNA to the ribosomal complex.

This inhibits bacterial protein synthesis and suppresses bacterial growth.

Its mechanism includes:

  • Binding to the bacterial 30S ribosomal subunit
  • Inhibition of aminoacyl-tRNA attachment
  • Inhibition of bacterial protein synthesis
  • Bacteriostatic antibacterial activity

Pharmaceutical Applications

Meclocycline API is used in pharmaceutical development for:

  • Acne vulgaris
  • Inflammatory acne-associated bacterial conditions
  • Topical bacterial skin infections
  • Dermatological antibacterial formulations
  • Tetracycline antibiotic research

Dermatological Applications

Meclocycline has historically been used primarily in topical dermatological preparations, particularly for acne. Topical delivery allows the active ingredient to be applied directly to affected skin.

Dosage Form Applications

Meclocycline may be incorporated into:

  • Topical creams
  • Topical gels
  • Dermatological preparations
  • Other topical antibacterial formulations

Physical Characteristics

Meclocycline is generally handled as a yellow to yellow-orange solid/powder, depending on the chemical form and grade. Physical characteristics should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Meclocycline manufacturing process may involve:

  1. Selection of qualified starting materials
  2. Preparation of tetracycline intermediates
  3. Controlled chemical modification
  4. Purification
  5. Salt formation where applicable
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Milling or sieving
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Meclocycline API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Water content
  • Residual solvents
  • Elemental impurities
  • Microbial quality
  • Particle-size distribution where applicable
  • Stability testing

Storage

Store Meclocycline API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Pharmaceutical Research

Meclocycline is relevant to research involving:

  • Tetracycline antibiotics
  • Bacterial protein synthesis
  • 30S ribosomal subunit
  • Dermatological infections
  • Acne
  • Topical antibiotic formulations
  • Antibacterial drug development
  • Dermatology pharmaceutical research

Meclocycline API Summary

Meclocycline is a tetracycline-class antibacterial pharmaceutical ingredient primarily associated with topical dermatological formulations. It has CAS Number 7381-01-3, molecular formula C21H21N3O8, and molecular weight 443.41 g/mol. Its antibacterial activity results from inhibition of bacterial protein synthesis through interaction with the 30S ribosomal subunit.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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