Search Results for: Solid Dosage Form

The aseptic production process is one of the most difficult process verifications in the preparation of sterile raw materials. Since many raw materials cannot be finally sterilized, the raw materials must be filtered, dried, pulverized, subpackaged, etc. as much as possible. Avoid microbial contamination. There are quite a lot of factors that affect the sterility […]

The impurity analysis in medicine is a very important part. The analysis of the important role of impurity source analysis focused on the development of analytical technology in the process of impurity research, especially the development of mass spectrometry in structure identification. At the same time, According to the guiding principles of foreign toxic impurities

Dropping pills are spherical preparations made from drugs and suitable matrix materials by mixing in the melted state and solidifying by dropping into an immiscible inert cooling media.   The manufacturing of dropping pills is related to the dropping method for soft capsules. The difference is that only one phase of the dropping fluid is

The research and development of an innovative drug needs to go through: disease market research, molecular mechanism research, target selection and confirmation, molecular design, synthesis and optimization of pilot compounds, pharmacodynamic pharmacokinesis and toxicity preliminary screening, preclinical research, clinical research, new drug review and listing, etc., from the establishment of new drugs to the final

1 Overview Of Cleaning Verification And Four Stages   In pharmaceutical enterprises, the same equipment may be used for the production of multiple products, and after the end of drug production, effective cleaning of the relevant equipment used in production is a necessary means to prevent drug contamination and cross-contamination. The provisions on cleaning and

This paper introduces several sterilization methods of sterile drugs : humid heat sterilization, dry heat sterilization, radiation sterilization, ethylene oxide sterilization and sterilization filtration, studies the sterilization principle, influencing factors, advantages and disadvantages of various sterilization methods, and products suitable for sterilization, etc., and selects the decision tree as the sterilization decision-making method of sterile

1. Tablet Preparation With Powder Compression     Tablets are a tablet-like solid formulation that is pressed after mixing the drug with suitable excipients, suitable for industrial production and easy to carry, and is one of the most important and widely used dosage forms in modern solid preparations. The preparation method of tablets can be divided

In view of the imperative application of QbD in China’s drug R&D, Dr. Wang Xingwang told R&D supervisors with a number of specific R&D examples: some QbD elements can be appropriately added at different stages of R&D, such as R&D objectives (QTPP), CQA, CMA, CPP and control strategies; QbD tools, such as risk assessment and

  Purpose    Taking the recovery rate as the entry point, the relevant concepts and practices of the cleaning residue analysis method in the cleaning verification of drugs are studied, which provides a reference for the research of residue analysis methods for pharmaceutical manufacturers in cleaning verification.   Methods   By consulting the relevant literature,

With the year-by-year development of large-scale production of pharmaceutical packaging, automation solutions for back-end packaging have been paid more and more attention. Relying on strong integration capabilities, Senieer provides a complete classic solution from filling to packing for various packaging forms.   Prefilled Syringe Solutions:   Out of the nest → light inspection → wring out the