Manufacturing Process of Guaiphenesin+Terbutaline+Ambroxol+Menthol Expectorant by Den Mark Pharmaceuticals Pvt. Ltd.
Den Mark Pharmaceuticals Pvt. Ltd. is committed to producing top-quality pharmaceutical products following the guidelines set by the World Health Organization's Good Manufacturing Practices (WHO GMP). This manufacturing process details the production of Guaiphenesin, Terbutaline, Ambroxol, and Mint Expectorant Syrup in compliance with these standards.
Raw Material:
- All raw materials, including Guaiphenesin, Terbutaline, Ambroxol, Menthol, excipients, and packaging materials, are procured from approved suppliers. Upon receipt, each batch undergoes rigorous quality testing to ensure compliance with specifications.
Weighing and Mixing:
- Guaiphenesin (50mg), Terbutaline (1.25mg), Ambroxol (15/30mg), and Menthol (1/1.5mg) are accurately weighed using precision equipment in a designated area.
- The weighed quantities are transferred to a clean, sanitized stainless steel vessel.
- Excipients such as preservatives, flavouring agents, sweeteners, and colorants are added per the formulation requirements.
- The mixture is homogenized using a high-shear mixer until a uniform blend is achieved.
Preparation of Expectorant:
Purified water is heated to a suitable temperature and added gradually to the homogenized mixture with constant stirring to form a suspension.
- The suspension is heated under controlled conditions to dissolve all ingredients thoroughly.
- The solution is then cooled to room temperature while maintaining continuous agitation to prevent sedimentation.pH adjustment uses suitable buffers to achieve the desired pH range for stability and effectiveness.
Filtration and Sterilization:
The syrup is passed through a sterile filtration system comprising sequential filters with decreasing pore sizes to remove particulate matter and microbial contaminants.
Sterilization is achieved through a validated process such as steam sterilization or sterile filtration under aseptic conditions to ensure product safety and efficacy.
Packaging:
The Guaiphenesin+Terbutaline+Ambroxol+Menthol Expectorant is poured into sterile glass or plastic bottles of appropriate size using automatic filling equipment to maintain accuracy and consistency.
- The filled bottles are securely capped and sealed under sterile conditions to prevent contamination during storage and transportation.
- Batch coding and labelling are applied to each bottle according to regulatory requirements, including product name, strength, batch number, expiry date, and manufacturing information.
Quality Control:
Samples from each batch undergo comprehensive quality control testing, including assay, impurity profiling, microbial limit testing, pH determination, viscosity measurement, and stability studies.
- Only batches that meet all specifications and quality standards are released for distribution.
Documentation and Record Keeping:
Detailed documentation of all manufacturing steps, including batch records, equipment logbooks, and quality control reports, is maintained per WHO GMP guidelines.
- Any deviations from standard procedures are documented, investigated, and resolved through a robust corrective and preventive action (CAPA) system.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd. a Bulk Drug and Contract Manufacturing Company India ensures the production of top-quality Guaiphenesin+Terbutaline+Ambroxol+Menthol Expectorant by adhering to WHO GMP guidelines throughout the manufacturing process. By prioritizing quality, safety, and efficacy, we aim to provide healthcare professionals and patients with reliable pharmaceutical products that meet the highest standards of excellence.