Doxycycline Hydrochloride

Doxycycline Hydrochloride API | Bulk Pharmaceutical Raw Material:

Doxycycline Hydrochloride is a broad-spectrum tetracycline antibiotic produced via semi-synthetic derivation from oxytetracycline. It functions via the inhibition of bacterial protein synthesis through reversible binding to the 30S ribosomal subunit. As a primary active pharmaceutical ingredient (API) for both human and veterinary formulations, this material is manufactured under current Good Manufacturing Practice (cGMP) standards to ensure low endotoxin levels, optimal flowability, and consistent assay values required for industrial-scale processing.

 

Product Specifications:

Complies with USP, EP, and BP pharmacopeial monographs.

Test Parameter	Specification Limits	Test Method
Appearance	Yellow crystalline powder	Visual Inspection
Identification	Positive for Doxycycline and Hydrochloride	USP / EP Monograph
Assay (Dried Basis)	95.0% - 102.0%	HPLC
pH (1% solution)	2.0 - 3.0	Potentiometry
Water Content (LOD)	<= 2.0% or 4.5% - 7.5% (hydrate form dependent)	Karl Fischer
Residue on Ignition	<= 0.4%	Gravimetric
Heavy Metals	<= 20 ppm	ICP-MS / Colorimetric
Related Substances	Any individual impurity <= 1.0%; Total <= 2.0%	HPLC

 

Chemical & Physical Properties:

Chemical Name: (4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-11-dioxo-2-naphthacenecarboxamide hydrochloride hemiethanolate hemihydrate

CAS Registry Number: 10592-13-9 (Hemiethanolate hemihydrate) / 24390-14-5 (Monohydrate)

Molecular Formula: C22H24N2O8 * HCl * 0.5C2H6O * 0.5H2O

Molecular Weight: 512.94 g/mol

Solubility: Freely soluble in water and in methanol; sparingly soluble in ethanol (96%).

Thermal Behavior: Decomposes at approximately 201 °C.

 

Applications:

Human Pharmaceuticals Formulation: Processing into oral capsules and tablets indicated for respiratory tract infections, acne vulgaris, chlamydial infections, and rickettsial diseases.

Veterinary Drug Manufacturing: Compounding into oral soluble powders, pastes, and medicated premixes for livestock production (swine, poultry, and cattle) targeting systemic bacterial pathogens.

 

Pharmaceutical Manufacturing Relevance:

Downstream Tableting Compatibility: Controlled micro-crystal morphology reduces particle agglomeration, maintaining uniform blending ratios across direct compression and dry granulation lines.

Dissolution Performance: Tailored particle size distribution (D90 < 75 um available) meets pharmacopeial disintegration and dissolution release criteria.

Hygroscopic Control: Low moisture affinity limits degradation risks during ambient humidity fluctuations in active manufacturing suites.

 

Grade & Quality Requirements:

Pharmacopeial Compliance: USP, EP, and BP monographs.

Facility Standard: Produced in dedicated synthesis facilities operating under ICH Q7 guidelines.

Batch Traceability: Full documentation trail from raw starting materials to final crystallization.

 

Quality Control:

Testing Protocol: Every production batch undergoes raw material verification, in-process reaction monitoring, and finished-product release testing.

Analytical Instrumentation: Validated high-performance liquid chromatography (HPLC) for assay and related substances, atomic absorption / ICP-MS for heavy metals, and Karl Fischer titration for moisture.

Retention Samples: Retained samples from all commercial batches are stored for 5 years under continuous temperature monitoring.

 

Technical Documents:

COA (Certificate of Analysis): Issued per batch, detailing exact HPLC assay results, impurity profiling, and physical test data.

SDS (Safety Data Sheet): GHS-compliant documentation detailing hazard identification, personal protective equipment requirements, and spill protocols.

TDS (Technical Data Sheet): Summary of physical parameters, handling constraints, and storage specifications.

 

Packaging & Storage:

Primary Packaging: Double-layer pharmaceutical-grade low-density polyethylene (LDPE) bags, heat-sealed.

Secondary Packaging: Fiber drums fitted with desiccant packets positioned between the liner and drum wall to prevent ambient moisture ingress.

Net Weight: 25 kg/drum.

Storage Conditions: Store below 25 °C in a dry, dark environment away from direct light. Keep containers tightly sealed.

Shelf Life: 36 months from the date of manufacture under specified storage parameters.

 

Supply & Procurement:

MOQ (Minimum Order Quantity): 25 kg (1 standard fiber drum) for laboratory evaluation or trial batching.

Sample Policy: 50g - 100g analytical samples provided for laboratory qualification. Freight costs apply.

Lead Time:

Spot orders: Dispatched within 7 business days from active inventory.

Scheduled bulk supply: 4 to 6 weeks for dedicated production campaigns.

Bulk Supply Capacity: Supported by continuous multi-ton annual manufacturing output under master supply agreements.

 

OEM / Custom Specification:

Particle Size Modification: Micronization services available to adjust particle size distribution (PSD) profiles for specialized dry powder or compression requirements.

Regulatory Support: Custom labeling configurations, specialized COA formatting, and documentation support for customer-specific supplier audits.

 

 

Request a Quote:
Submit required volumes, destination port specifications, and pharmacopeial edition requirements (USP/EP) to receive a commercial quotation including FOB or CIF terms.
Email: Kelvinsong1982@yimingbiotech.com.cn
Direct Inquiry: Complete the specification request form on our secure portal for a formal response within 24 business hours.

 

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