Manufacturer of Acido D Malico - 1-(4-METHOXYPHENYL)METHANAMINE – Gentolex

Product Detail

Synonyms

 LABOTEST-BB LTBB000703; AKOS BBS-00003589; 4-AMINOMETHYL-ANISOLE; 4-METHOXYBENZYLAMINE; P-Methoxybenzylamine Hydrochloride173.64; 4-Methoxybenzylamine, 98+%; for Sparfloxacine; P-METHOXYBENZYLAMINE HYDROCHLORIDE

Application

It can be used for the synthesis of pharmaceutical intermediates. It is slightly harmful to water. Do not let undiluted or large quantities of products come into contact with groundwater, waterways or sewage systems. Without government permission, do not discharge materials into the surrounding environment to avoid oxides, acids. , air, carbon dioxide contact, keep the container sealed, put it in a tight extractor, and store in a cool, dry place.

QC Lab

An individual QC laboratory stands in the site where chemical, physical test, microbial test, stability study, instrument test such as IR, UV, HPLC, GC are performed for raw materials and finished products. The whole area is access controlled and well maintained with sufficient analytical instruments for intended testing purpose. All instruments are well labelled and appropriately calibrated.

QA

QA is responsible to evaluate and categorize the deviation into Major level, General level and Minor level. For all levels of deviations, the investigation to identify the root cause or potential cause is necessary. Investigation needs to be completed within 7 working days. The product impact assessment along with CAPA plan are also required after the investigation complete and root cause identified. The deviation is closed when the CAPA is implemented. All Level deviation should be approved by QA Manager. After implemented, effectiveness of CAPA is confirmed based on plan.