Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride is a broad-spectrum synthetic fluoroquinolone antibacterial raw material. It functions by inhibiting bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription. Manufactured for secondary pharmaceutical processing under cGMP guidelines in a WHO-GMP and FDA-inspected manufacturing facility, this active pharmaceutical ingredient (API) serves as the primary raw material for producing solid, liquid, and topical anti-infective formulations targeting Gram-negative and Gram-positive bacterial strains.

 

Product Specifications:

International Nonproprietary Name (INN): Ciprofloxacin Hydrochloride Monohydrate

Chemical Name: 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-quinoline-3-carboxylic acid hydrochloride monohydrate

CAS Registry Number: 86393-32-0

Molecular Formula: C17H18FN3O3 * HCl * H2O

Molecular Weight: 385.82 g/mol

Pharmacopoeial Compliance: USP / EP / BP

Identification: Infrared absorption spectrophotometry conforms to USP/EP reference standards; positive reaction for chlorides.

 

Chemical & Physical Properties:

Appearance: Pale yellow to faint yellow crystalline powder

Solubility: Sparingly soluble in water; slightly soluble in methanol; very slightly soluble in anhydrous ethanol; practically insoluble in acetone and ethyl acetate.

pH (2.5% aqueous suspension): 3.0 to 4.5

Specific Optical Rotation: Not applicable (achiral molecule)

Loss on Drying: 4.9% to 6.7% (determined on a 1.000 g sample by drying in an oven at 105 deg C for 3 hours)

Residue on Ignition (Sulfated Ash): Maximum 0.1%

Heavy Metals: Maximum 20 ppm

Particle Size Distribution (PSD): D90 < 75 um (micronized grade available upon request for suspension or ophthalmic applications)

 

Applications:

Human Pharmaceuticals:

Oral solid dosage forms: Film-coated tablets (250 mg, 500 mg, 750 mg) for urinary tract infections, respiratory tract infections, and abdominal infections.

Parenteral formulations: Intravenous infusion solutions (2 mg/mL).

Topical preparations: Ophthalmic and otic drops for bacterial conjunctivitis and external ear infections.

Veterinary Pharmaceuticals: Formulated into water-soluble powders and oral solutions for livestock and poultry bacterial pathogen control under strict veterinary oversight.

 

Pharmaceutical Manufacturing Relevance:

Excipient Compatibility: Compatible with standard solid-dosage excipients including microcrystalline cellulose, corn starch, croscarmellose sodium, and magnesium stearate. Direct compression or wet granulation processing parameters require standard moisture management due to monohydrate stability limits.
Processability: Exhibits consistent flowability (Carr index: 18 to 22; Hausner ratio: 1.22 to 1.28) suited for high-speed rotary tablet presses. Micronized variants reduce dissolution time in liquid and suspension manufacturing lines.

 

Grade & Quality Requirements:

Regulatory Standard: Produced in accordance with current Good Manufacturing Practice (cGMP) guidelines ICH Q7. Facility holds valid WHO-GMP certification with audit histories supporting regulatory filings across North America, the EU, and Asia-Pacific markets.

Impurities Profile: Individual specified impurities controlled below 0.10% in compliance with ICH Q3A/Q3B thresholds. Total impurities controlled below 0.5%.

Residual Solvents: Manufactured using Class 3 solvents (e.g., ethanol, acetic acid) with residual levels verified well below ICH Q3C limits.

Microbiological Limits:

Total Aerobic Microbial Count (TAMC): < 1000 CFU/g

Total Yeast and Mold Count (TYMC): < 100 CFU/g

Escherichia coli: Absent in 1 g

Bacterial Endotoxins: < 0.25 IU/mg (for parenteral grade)

 

Quality Control:

Analytical Methodology: Tested via validated High-Performance Liquid Chromatography (HPLC) for assay and related substances, titration for chloride content, and Karl Fischer titration for water determination.
Batch Release Testing: Every commercial batch undergoes complete physical, chemical, and microbiological testing prior to release. Retention samples (at least twice the quantity required for complete analytical testing) are stored for 1 year beyond expiry date under controlled ICH stability conditions.
Stability Data: Real-time stability data available at 25 deg C +/- 2 deg C / 60% RH +/- 5% RH (36 months) and accelerated stability data at 40 deg C +/- 2 deg C / 75% RH +/- 5% RH (6 months).

 

Technical Documents:

COA (Certificate of Analysis): Batch-specific COA detailing exact assay, impurity breakdown, moisture, particle size, and microbial parameters available for download.

SDS (Safety Data Sheet): Hazard identification, handling precautions, spill response, and toxicological data conforming to GHS standards available for download.

TDS (Technical Data Specification): Physical property metrics, recommended storage conditions, shelf-life parameters, and packaging configurations available for download.

Regulatory Documentation: Active Drug Master File (DMF) registered with global health authorities. Letters of Access (LoA) issued under confidentiality agreement (CDA) to support generic drug submissions.

 

Packaging & Storage:

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

Secondary Packaging: Fiber drums or rigid HDPE drums with tamper-evident security seals.

Net Weight: 25 kg per drum (custom 5 kg or 10 kg packaging available for clinical trial scale quantities).

Storage Conditions: Store in tightly closed containers below 30 deg C, protected from light, moisture, and direct heat sources.

Shelf Life: 36 months from the date of manufacture when stored under specified conditions.

 

Supply & Procurement:

MOQ (Minimum Order Quantity): 25 kg (one standard drum) for commercial evaluation; pilot trial quantities negotiable upon inquiry.

Sample Policy: 100 g analytical samples available for laboratory evaluation and method validation, shipped alongside current lot COA and SDS.

Lead Time:

Ex-stock orders: Dispatch within 5 to 7 business days.

Scheduled production runs: 3 to 4 weeks from order confirmation.

Bulk Supply Capacity: Annual tonnage commitments supported by dedicated multi-batch campaign production lines. Long-term supply agreements (LTAs) available with fixed-price protection and rolling forecasts.

 

OEM / Custom Specification:

Particle Size Customization: Milling options available to meet specific particle size distribution ranges (D50 and D90) required for specialized inhalation or suspension formulations.
Custom Documentation: Tailored labeling, customized COA parameter formatting, and pre-shipment inspection reports accommodated to align with client Quality Assurance (QA) intake protocols.

 

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