Tetracycline Hydrochloride

Tetracycline Hydrochloride | Bulk API & Raw Material Specification:

Tetracycline Hydrochloride is a broad-spectrum polyketide antibiotic derived from Streptomyces species, supplied as a crystalline active pharmaceutical ingredient (API) for secondary pharmaceutical processing, veterinary formulation, and chemical synthesis. It operates via reversible binding to the bacterial 30S ribosomal subunit, halting peptide chain elongation and protein translation. Production utilizes controlled submerged fermentation followed by multi-stage crystallization and purification protocols, adhering to current Good Manufacturing Practice (cGMP) standards to ensure batch-to-batch consistency for downstream formulators.

 

Product Specifications:

Lot release testing conforms strictly to United States Pharmacopeia (USP) and European Pharmacopoeia (EP) monographs.

Parameter	Specification Standard	Test Method
Identification	Positive for Hydrochloride and Tetracycline	Infrared Absorption (IR) / HPLC
Assay (Dried Basis)	98.0% to 102.0%	High-Performance Liquid Chromatography (HPLC)
Specific Optical Rotation	-239° to -258°	Polarimetry (1% in 0.1 M HCl)
Loss on Drying	<= 2.0%	Gravimetric (105°C, 3 h)
Residue on Ignition	<= 0.5%	Platinum Crucible Incineration
Heavy Metals	<= 50 ppm	Colorimetric Sulfide Precipitation
pH (1% Solution)	1.8 to 2.8	Potentiometric Titration
Light-Absorbing Impurities	Conforms to monograph limits	UV-Vis Spectrophotometry

 

Chemical & Physical Properties:

CAS Number	64-75-5
Molecular Formula	C22H24N2O8 · HCl
Molecular Weight	480.90 g/mol
Appearance	Yellow to light-yellow, odorless, crystalline powder
Solubility	Soluble in water (approx. 1 g in 10 mL); slightly soluble in ethanol (96%); practically insoluble in ether or chloroform
Stability	Hygroscopic; undergoes epimerization and degradation when exposed to alkaline media, prolonged direct sunlight, or temperatures exceeding 30°C

 

 Applications:

Human Pharmaceuticals: Raw material for manufacturing oral capsules, film-coated tablets, and topical ophthalmic suspensions targeting susceptible bacterial pathogens.

Veterinary Formulations: Active ingredient utilized in water-soluble powders, oral premixes, and boluses for livestock and aquaculture therapeutics.

Chemical Synthesis: Precursor intermediate for specialized organic synthesis and biochemical research requiring an intact naphthacene-carboxamide core.

 

Pharmaceutical Manufacturing Relevance:

Particle Size Distribution (PSD): Controlled jet-milling achieves D90 < 75 um, preventing particle segregation during direct compression and maintaining uniform content uniformity in solid oral dosage forms.

Flowability Parameters: Bulk density maintained between 0.42 g/cm3 and 0.58 g/cm3 to prevent hopper bridging and minimize weight variance on high-speed rotary tablet presses.

Dissolution Profile: In vitro dissolution testing verifies > 80% drug release within 30 minutes in 0.1 M HCl, supporting generic bioequivalence requirements.

 

Grade & Quality Requirements:

Compendial Compliance: USP / EP / BP grade.

Regulatory Documentation: Manufactured in ISO 9001 and cGMP-certified production lines. Active Drug Master File (DMF) registered with the US FDA and Certificate of Suitability (CEP) issued by the EDQM available for filing support.

Impurity Limits: Individual related substances controlled below 0.5% and total degradation products (including 4-epianhydrotetracycline) maintained below 2.0% via gradient HPLC monitoring.

 

Quality Control:

In-Process Control (IPC): Fermentation broth parameters, extraction efficiency, and crystallization temperature gradients are monitored across every production run.

Chromatographic Purity Checks: Every commercial lot is tested via HPLC equipped with photodiode array (PDA) detectors to verify absence of cross-contamination and degradation peaks.

Retention Samples: Reference samples from every manufactured lot are archived for 5 years in temperature- and humidity-controlled storage lockers for traceability audits.

 

Technical Documents:

COA (Certificate of Analysis): Lot-specific analytical data, including exact assay, moisture content, specific rotation, and impurity profiles, accompany every shipment.

SDS (Safety Data Sheet): GHS-compliant documentation detailing toxicological data, personal protective equipment (PPE) requirements, spill response, and waste disposal protocols.

TDS (Technical Data Sheet): Comprehensive physical constants, recommended handling conditions, and storage specifications available for technical dossiers.

 

Packaging & Storage:

Primary Packaging: Double-layer food-grade low-density polyethylene (LDPE) bags, heat-sealed under vacuum to eliminate moisture contact.

Secondary Packaging: 25 kg fiber drums fitted with tamper-evident security locking rings.

Storage Conditions: Store in tightly closed containers below 25°C, protected from light and humidity. Shelf life is 36 months from the manufacture date under specified storage conditions.

 

Supply & Procurement:

MOQ (Minimum Order Quantity): 25 kg (One standard fiber drum).

Sample Policy: 50 g to 100 g analytical samples provided for laboratory evaluation alongside a lot-specific COA (shipping freight applies).

Lead Time:

Ex-stock shipments: Dispatched within 3 to 5 business days.

Bulk production runs: 15 to 25 business days for orders exceeding 1 metric ton.

Bulk Supply Capacity: Annual production output exceeds 500 metric tons, supporting Annual Supply Agreements (ASAs) with fixed-price windows and phased delivery schedules.

 

OEM / Custom Specification:

Custom Milling: Dedicated air-jet milling services available to achieve client-specific particle size distribution profiles.

Private Labeling: Customized drum artwork, GS1-128 barcode integration, and client-specified document headers for supply chain integration.

Alternative Packaging: Aluminum-lined barrier bags or alternative net-weight drum configurations available upon contract agreement.

 

 

Request a Quote:
Submit required quantity, destination port, and compendial standard (USP/EP) to receive a commercial quotation inclusive of landed cost estimates and current batch COA documentation.

 

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