Introduction
Den Mark Pharmaceuticals Pvt. specializes in crafting top-tier Sertaconazole Nitrate Cream (2% w/w), meticulously formulated for efficacy and safety. Our cream embodies excellence, meticulously synthesized in state-of-the-art facilities under stringent quality controls. Each batch undergoes rigorous testing to ensure potency and purity, meeting international standards.
The cream offers unparalleled relief from fungal infections and precisely addresses diverse dermatological concerns. Utilizing cutting-edge technology and premium ingredients, our product stands as a beacon of quality and reliability. From its smooth texture to its rapid absorption, every aspect reflects our unwavering commitment to delivering excellence in skincare. Experience the pinnacle of pharmaceutical craftsmanship with Den Mark Pharmaceuticals Pvt.
Raw Material Selection and Testing: Den Mark Pharmaceuticals procures raw materials from approved suppliers, ensuring compliance with pharmacopeial standards. Before acceptance, each raw material undergoes stringent testing for identity, purity, potency, and microbial contamination.
Formulation: The formulation of Sertaconazole Nitrate Cream follows a precise recipe:
- Active Ingredient Preparation: Sertaconazole Nitrate is accurately weighed and dissolved in a suitable solvent under controlled conditions to achieve the desired concentration.
- Excipient Preparation: Excipients, including emulsifiers, preservatives, stabilizers, and emollients, are selected based on compatibility and functionality. They are weighed, mixed, and heated to form a homogeneous mixture.
- Cream Preparation: The active ingredient solution is gradually added to the excipient mixture with continuous stirring to ensure uniform dispersion. The emulsion is then cooled while maintaining agitation to obtain a smooth cream base.
Manufacturing Process:
- Individually weigh each raw material according to the pre-determined production batch size and documented master formula.
- Mill the Hydroquinone, Tretinoin, and Mometasone Furoate to ensure proper particle size and dispersion within the cream.
Mixing Phase: The cream base is transferred to a mixing vessel equipped with a homogenizer. The active ingredient solution is added slowly under constant agitation to achieve uniform distribution.
Homogenization: The mixture undergoes homogenization to reduce particle size and ensure uniformity. This step is critical for achieving consistent drug content in each batch.
Sterilization: The cream is sterilized using validated methods such as filtration or heat treatment to eliminate microbial contamination without compromising product stability.
Filling and Packaging: The sterile cream is filled into pre-sterilized tubes or containers using automated filling equipment under controlled conditions to prevent contamination. Proper labelling with product information and batch details is applied.
Quality Control: Each batch of Sertaconazole Nitrate Cream (2% w/w) undergoes comprehensive quality control tests, including assay, content uniformity, pH, viscosity, microbial limits, and stability testing as per WHO GMP guidelines.
Stability Testing: Finished Sertaconazole Nitrate Cream (2% w/w) is placed under accelerated and long-term stability testing to evaluate its shelf-life under various storage conditions.
Batch Release: Only batches that meet all quality specifications are released for distribution.
Quality Assurance: Den Mark Pharmaceuticals prioritizes quality assurance at every stage of the manufacturing process. This includes stringent control of environmental conditions, personnel training, equipment calibration, and documentation practices to ensure compliance with WHO GMP guidelines.
Conclusion: Den Mark Pharmaceuticals Pvt. Ltd.'s Sertaconazole Nitrate Cream (2% w/w) manufacturing process is designed and executed with precision and adherence to WHO-GMP guidelines. Through rigorous quality control measures and meticulous attention to detail, Den Mark Pharmaceuticals produces pharmaceutical products of the highest quality and efficacy.