Excipients for pharmaceuticals
Found 8 free book(s)
Qualification of Excipients for Use in Pharmaceuticals
ipecamericas.orgMany materials used as excipients have applications other than in pharmaceuticals, such as food additives, cosmetics, or industrial products. Thus, environmental conditions, equipment, and
Strategic Approach Pharmaceuticals - European Commission
ec.europa.euMar 11, 2019 · (excipients) other than the active substance and the packaging material. 2 COM (2008) 666 Final: Communication from the Commission to the European Parliament, the Council, ... pharmaceuticals at or even below the low concentrations found in water and soil16. For example, male fish exposed to such concentrations of the main ingredient in the ...
232 ELEMENTAL IMPURITIES—LIMITS
www.usp.orgfor pharmaceuticals. Thus, the limit was established assuming the most common (mercuric) inorganic form. Limits for articles ... The concentration of elemental impurities in drug substances and excipients must be controlled and, where present, docu-mented. The acceptable levels for these impurities depend on the material's ultimate use.
Quality assurance of pharmaceuticals - WHO
www.who.intPharmaceutical excipients 196 3. WHO good manufacturing practices: specific pharmaceutical products 215 Sterile pharmaceutical products 215 Biological products 232 Investigational pharmaceutical products for clinical trials in humans 242 The manufacture of herbal medicines (updated) 254 Radiopharmaceutical products 276 4. Inspection 285
Q8 (R2) Step 5 Pharmaceutical Development
www.ema.europa.eu2.1.2. Excipients The excipients chosen, their concentration, and the characteristics that can influence the drug product performance (e.g., stability, bioavailability) or manufacturability should be discussed relative to the respective function of each excipient. This should include all substances used in the manufacture of the
THE COMMON TECHNICAL DOCUMENT FOR THE …
database.ich.orgTHE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY QUALITY OVERALL SUMMARY OF MODULE 2 MODULE 3 : QUALITY ICH HARMONISED TRIPARTITE GUIDELINE Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November …
INTERNATIONAL CONFERENCE ON HARMONISATION OF …
database.ich.orgdevelopment of separate guidelines covering excipients, source materials for biologicals and target materials for radiopharmeceuticals. Background/Status quo: There are several different GMP guidelines for starting materials. There is the 1987 PIC (Pharmaceutical Inspection Convention) guideline on GMP for active ingredients.
Prescribing Information | Gvoke® (glucagon injection)
www.gvokeglucagon.com• Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)]. 5 WARNINGS AND PRECAUTIONS 5.1 Substantial Increase in Blood Pressure in Patients Pheochromocytoma