01 2DDP SPECIALTY ELECTRONIC MATERIALS US9 LLC Hemlock US
01 1Dimeticone, 20, 100, 350, 500, 1000 mm2.s-1
02 1Silicone oil used as a lubricant (3.1.8.), 12500 mm2s-1
01 2U.S.A
01 2Valid
Dimeticone, 20, 100, 350, 500, 1000 Mm2.s-1
Certificate Number : R2-CEP 1995-047 - Rev 02
Status : Valid
Issue Date : 2019-03-04
Type : Chemical
Substance Number : 138
Silicone Oil Used As A Lubricant (3.1.8.), 12500...
Certificate Number : R2-CEP 1995-049 - Rev 02
Status : Valid
Issue Date : 2019-03-06
Type : Chemical
Substance Number : 30108
66
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A Syltherm 800 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Syltherm 800, including repackagers and relabelers. The FDA regulates Syltherm 800 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Syltherm 800 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Syltherm 800 supplier is an individual or a company that provides Syltherm 800 active pharmaceutical ingredient (API) or Syltherm 800 finished formulations upon request. The Syltherm 800 suppliers may include Syltherm 800 API manufacturers, exporters, distributors and traders.
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A Syltherm 800 CEP of the European Pharmacopoeia monograph is often referred to as a Syltherm 800 Certificate of Suitability (COS). The purpose of a Syltherm 800 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Syltherm 800 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Syltherm 800 to their clients by showing that a Syltherm 800 CEP has been issued for it. The manufacturer submits a Syltherm 800 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Syltherm 800 CEP holder for the record. Additionally, the data presented in the Syltherm 800 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Syltherm 800 DMF.
A Syltherm 800 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Syltherm 800 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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