Complete Technical Specifications

Comprehensive product and manufacturing details for Tinidazole tablets

Product Specifications

Tinidazole 250mg

Strength	250mg per tablet
Dosage Form	Film-coated tablets
Active Ingredient	Tinidazole USP
Packaging	Blister packs (10 tablets per strip)
Storage Conditions	Store at room temperature (15-30°C), protect from moisture and light
Shelf Life	36 months from date of manufacture
Appearance	White to off-white, round, film-coated tablets
Tablet Weight	Approximately 450-550mg

Tinidazole 300mg

Strength	300mg per tablet
Dosage Form	Film-coated tablets
Active Ingredient	Tinidazole USP
Packaging	Blister packs (10 tablets per strip)
Storage Conditions	Store at room temperature (15-30°C), protect from moisture and light
Shelf Life	36 months from date of manufacture
Appearance	White to off-white, round, film-coated tablets
Tablet Weight	Approximately 500-600mg

Tinidazole 500mg

Strength	500mg per tablet
Dosage Form	Film-coated tablets
Active Ingredient	Tinidazole USP
Packaging	Blister packs (10 tablets per strip)
Storage Conditions	Store at room temperature (15-30°C), protect from moisture and light
Shelf Life	36 months from date of manufacture
Appearance	White to off-white, round, film-coated tablets
Tablet Weight	Approximately 600-700mg

Manufacturing Standards & Compliance

WHO-GMP Certification

Taj Pharma's manufacturing facility operates under strict WHO-GMP (Good Manufacturing Practice) standards, ensuring that every batch of Tinidazole meets international quality requirements.

WHO-GMP certified production facility
Regular audits and inspections
Continuous compliance monitoring
Documentation and traceability systems

International Standards

ISO 9001:2015 - Quality Management System
ISO 14001:2015 - Environmental Management
OHSAS 18001 - Occupational Health & Safety
USP Standards - United States Pharmacopeia
BP Standards - British Pharmacopoeia
IP Standards - Indian Pharmacopoeia

Manufacturing Process Overview

Raw Material Selection

Premium quality raw materials sourced from certified suppliers and thoroughly tested before use

Formulation & Mixing

Precise formulation and mixing of active pharmaceutical ingredients with excipients under controlled conditions

Tablet Compression

Advanced tablet compression machinery ensures uniform weight, hardness, and dissolution characteristics

Film Coating

Automated coating equipment applies uniform protective coating for stability and ease of administration

Quality Control Testing

Rigorous testing ensures every batch meets WHO-GMP standards and regulatory requirements

Packaging & Distribution

Automated packaging in blister packs with proper labeling, batch tracking, and climate-controlled storage

Quality Control & Testing Procedures

Quality Testing Procedures

Raw Material Testing

All raw materials undergo rigorous testing before use in production to ensure purity and quality standards

In-Process Testing

Continuous monitoring during manufacturing to ensure consistency and adherence to specifications

Finished Product Testing

Comprehensive analysis of final tablets including potency, dissolution, and physical characteristics

Stability Testing

Long-term shelf-life verification under various temperature and humidity conditions

Microbial Testing

Sterility and contamination checks for bacterial, fungal, and other microbial presence

Impurity Analysis

Detection and quantification of any impurities to ensure product safety and purity standards

Advanced Testing Methods

Test Method	Purpose	Standard
HPLC (High-Performance Liquid Chromatography)	Ensures accurate active ingredient content in every tablet	USP/BP/IP
Dissolution Testing	Verifies proper tablet dissolution for optimal bioavailability	USP/BP/IP
Hardness Testing	Measures tablet strength and durability	USP/BP/IP
Friability Testing	Ensures tablets don't crumble during handling and packaging	USP/BP/IP
Weight Variation	Confirms uniform tablet weight within acceptable limits	USP/BP/IP
Moisture Content	Determines water content to ensure stability	USP/BP/IP
Microbial Limits	Tests for bacterial and fungal contamination	USP/BP/IP
Related Substances	Identifies and quantifies impurities and degradation products	USP/BP/IP

Technical & Pharmacological Data

Chemical Composition

Chemical Name	1-(2-Ethylsulfinyl-ethyl)-2-methyl-5-nitroimidazole
Molecular Formula	C₇H₁₃N₃O₃S
Molecular Weight	219.26 g/mol
Physical Form	White to off-white crystalline powder
Solubility	Slightly soluble in water

Pharmacological Properties

Mechanism of Action: Inhibits DNA synthesis in protozoal organisms
Therapeutic Class: Antiprotozoal agent
Absorption: Rapidly and completely absorbed from GI tract
Distribution: Widely distributed in body tissues and fluids
Metabolism: Hepatic metabolism
Elimination: Primarily renal excretion
Half-life: Approximately 12-14 hours

Stability Data

Storage Stability: Stable at 25°C/60% RH for 36 months
Accelerated Stability: Stable at 40°C/75% RH for 6 months
Intermediate Stability: Stable at 30°C/65% RH for 12 months
Light Stability: Protected from direct sunlight
Moisture Sensitivity: Protect from moisture and humidity
Temperature Range: 15-30°C recommended storage

Bioavailability Information

Oral Bioavailability: Approximately 90-100%
Peak Plasma Concentration: 1-2 hours after administration
Protein Binding: Approximately 12%
Volume of Distribution: Approximately 0.8 L/kg
Food Effect: Absorption not significantly affected by food
Bioequivalence: Meets USP/BP bioequivalence standards

Regulatory Compliance

Regulatory Status	Approved by regulatory authorities in multiple countries
Pharmacopeial Standards	Complies with USP, BP, and IP monographs
Manufacturing Compliance	WHO-GMP certified production facility
Quality Standards	Exceeds international quality requirements
Documentation	Complete batch records and certificates of analysis available
Traceability	Full traceability from raw materials to finished product

Technical Specifications