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Doxycycline Hyclate BP
Doxycycline Hyclate BP is a broad-spectrum, semisynthetic tetracycline-class antibiotic available as the hemihydrate salt form of doxycycline. It is widely used in pharmaceutical formulations due to its high bioavailability, broad antibacterial activity, and favorable pharmacokinetic profile. The compound exhibits bacteriostatic action by inhibiting protein synthesis in susceptible bacteria, making it effective against a wide range of Gram-positive and Gram-negative organisms as well as atypical pathogens. It is typically supplied as a fine, white to off-white crystalline powder soluble in water and suitable for oral and parenteral dosage forms.
Description
Doxycycline Hyclate BP
Primary UsesÂ
- Pharmaceutical Industry
- Used as an active pharmaceutical ingredient (API) in oral tablets, capsules, and suspensions for the treatment of bacterial infections.
- Formulated in injectable solutions for severe infections requiring intravenous administration.
- Effective against respiratory tract infections (e.g., pneumonia, bronchitis), urinary tract infections, skin infections, and sexually transmitted diseases.
- Used to treat atypical infections such as chlamydia, mycoplasma, and rickettsial infections (e.g., Rocky Mountain spotted fever).
- Applied in treatment regimens for Lyme disease, malaria prophylaxis, and acne vulgaris.
- Veterinary Medicine
- Used in veterinary formulations for treatment of bacterial infections in livestock, pets, and poultry.
- Helps in management of respiratory, urinary, and dermatological infections in animals.
- Research and Development
- Employed in microbiological studies and pharmaceutical research to evaluate antibacterial efficacy and resistance profiles.
- Used as a reference standard in analytical and formulation development.
Secondary UsesÂ
- Dental Medicine
- Utilized in periodontal therapy formulations due to its activity against periodontal pathogens.
- Incorporated in topical gels and rinses for localized treatment of gum infections.
- Combination Therapy
- Used in combination with other antimicrobials for synergistic effects against resistant bacteria.
- Incorporated in formulations for treatment of acne and rosacea.
- Prophylactic Applications
- Administered prophylactically for prevention of bacterial infections in immunocompromised patients and during surgeries.
- Carcinogenicity/Mutagenicity: Not classified
KEY ATTRIBUTES
- Basic Identification Attributes
- Chemical Name (IUPAC): (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hemihydrate
- Common/Trade Name: Doxycycline Hyclate BP
- CAS Number: 24390-14-5
- HS Code: 2941.20.00
- Molecular Formula: C₂₂H₂₄N₂O₈·0.5H₂O
- Synonyms:
- Doxycycline hemihydrate
- Doxycycline monohydrate (sometimes used interchangeably but distinct)
- Tetracycline derivative
- Physical & Chemical Properties
- Physical State: White to off-white crystalline powder
- Odor: Odorless to slight medicinal odor
- Solubility: Soluble in water (25 mg/mL approx.), freely soluble in methanol, slightly soluble in ethanol
- Melting Point: 196–201°C (decomposes)
- pH (1% aqueous solution): 2.5–3.5
- Stability: Sensitive to light, moisture, and heat; degrades in acidic and alkaline conditions
- Safety & Hazard Attributes
- Hazard Class (GHS): Not classified as hazardous but precaution required due to antibiotic nature
- Toxicity: Low acute toxicity; potential for hypersensitivity and photosensitivity reactions
- Exposure Limits: No established occupational limits; handle with care to avoid sensitization
- Storage & Handling Attributes
- Storage Conditions: Store in airtight containers protected from light and moisture, at 15–25°C
- Container Type: Amber glass bottles, sealed HDPE containers
- Shelf Life: 2–3 years if stored properly
- Handling Precautions: Avoid exposure to moisture and light; use PPE to avoid inhalation and skin contact
- Regulatory & Compliance Attributes
- Compliant with British Pharmacopoeia (BP) standards
- Approved for use in human and veterinary pharmaceuticals
- Registered and monitored under pharmaceutical regulatory authorities (FDA, EMA, etc.)
- Environmental & Health Impact
- Ecotoxicity: Moderate; potential effects on aquatic microorganisms if released untreated
- Persistence: Degrades under environmental conditions but may persist if concentrated
- Bioaccumulation: Low potential
- Carcinogenicity/Mutagenicity: Not classified as carcinogenic or mutagenic
- Biodegradability: Moderate
SAFETY HANDLING PRECAUTIONS
Safety Handling Precautions
PPE Required:
- Gloves (nitrile or latex)
- Safety goggles
- Lab coat or protective apron
- Dust mask or respirator when handling powder in bulk
Handling Guidelines:
- Handle in well-ventilated areas to avoid inhalation of dust
- Avoid skin and eye contact
- Prevent cross-contamination in manufacturing environments
Storage Measures:
- Store in tightly closed containers away from moisture and light
- Maintain cool and dry conditions
- Avoid storage near incompatible substances (strong oxidizers, acids)
Hygiene Practices:
- Wash hands thoroughly after handling
- Avoid eating, drinking, or smoking while handling
- Use clean equipment and work surfaces
First Aid Measures
- Inhalation: Move to fresh air; seek medical attention if respiratory symptoms develop
- Skin Contact: Wash affected area with soap and water; seek medical advice if irritation occurs
- Eye Contact: Rinse eyes with plenty of water for at least 15 minutes; seek medical attention if irritation persists
- Ingestion: Rinse mouth; do not induce vomiting; seek immediate medical attention
Firefighting Measures
- Fire Hazards: Combustible material but low flammability in powder form
- Extinguishing Media: Water spray, dry chemical, foam, or COâ‚‚
- Special Precautions: Use self-contained breathing apparatus in confined spaces
- Decomposition Products: Carbon oxides, nitrogen oxides, and other toxic fumes on combustion
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