Doxycycline Hyclate BP

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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.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Antibacterial Agent, Antibiotic, BP Standard, Doxycycline Hyclate, Livestock Medication, Pharmaceutical Grade

Description

Table of Contents

Doxycycline Hyclate BP Uses

Primary Uses

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 Uses

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.

KEY PRODUCT FEATURES

1. 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

2. 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

3. 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

4. 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

5. 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.)

6. 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 CO₂
Special Precautions: Use self-contained breathing apparatus in confined spaces
Decomposition Products: Carbon oxides, nitrogen oxides, and other toxic fumes on combustion