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IPEC (International Pharmaceutical Excipients Council) is a global non-profit industry organization composed of five major regional associations worldwide: IPEC US, IPEC Europe, IPEC Japan, IPEC China, and IPEC India. It is committed to developing quality, safety, and management standards for pharmaceutical excipients. Products of IPEC grade generally refer to pharmaceutical excipients that comply with the IPEC-PQG GMP Guidelines or other IPEC standards, ensuring their applicability and safety in the pharmaceutical industry.
Stakeholders of the IPEC Association
Excipients of IPEC grade must comply with the following core standards:
(1) GMP Compliance
· Production meets the IPEC-PQG GMP Guidelines (or equivalent standards)
· Ensure that the production environment, equipment, processes, and document management comply with GMP requirements
(2) Safety Assessment
· Comply with IPEC safety assessment guidelines to ensure the safety of excipients in pharmaceuticals
· Provide toxicological data (e.g., ICH-Q3D elemental impurity control)
(3) Supply Chain Traceability
· Comply with IPEC GDP (Good Distribution Practice) to ensure that transportation and storage meet requirements
· Provide complete batch records and Certificate of Analysis (COA)
(4) Pharmacopoeia Compliance
· Comply with pharmacopoeial standards such as USP/EP/JP/ChP (e.g., microbial limits, heavy metals, residual solvents, etc.)
Therefore, IPEC-grade products have the following advantages:
|
Advantage |
Description |
|
High quality standard |
Complies with international GMP and pharmacopoeial requirements, Ensures stable quality of excipients |
|
Safety Assurance
|
After strict safety assessment, the risk of pharmaceuticals is reduced. |
|
Reliable Supply Chain |
Complies with GDP standards to ensure compliance in transportation and storage |
|
Global Recognition
|
Suitable for regulatory markets such as the FDA, EMA, and NMPA |
|
Reduce approval barriers |
Pharmaceutical companies can pass regulatory audits more easily. |
IPEC-grade pharmaceutical excipients are high-standard products in the pharmaceutical industry, complying with international GMP, safety assessment, and supply chain management requirements. As a leading supplier of biochemical reagents and pharmaceutical raw materials in Europe, AppliChem has continuously optimized its IPEC-grade product line and became an official member of IPEC Europe in 2025.
The details of AppliChem products are as shown in the table below.
|
Item Number |
Name |
CAS |
|
631339 |
Glycerol(Ph.Eur,BP,USP)IPEC grade |
56-81-5 |
|
631404 |
MagnesiumSulfate7-hydrate(Ph.Eur,BP)IPEC grade |
10034-99-8 |
|
631396 |
MagnesiumChloride6-hydrate(Ph.Eur.,BP)IPEC grade |
7791-18-6 |
|
631632 |
SodiumAcetate3-hydrate(Ph.Eur,BP,USP)IPEC grade |
6131-90-4 |
|
631638 |
SodiumHydrogenCarbonate(Ph.Eur,BP,USP)IPEC grade |
144-55-8 |
|
631655 |
tri-SodiumCitrate2-hydrate(Ph.Eur,BP,USP)IPEC grade |
6132-04-3 |
|
637763 |
N-Acetyl-DL-Tryptophan(Ph.Eur,BP)lowendotoxin,IPEC grade |
87-32-1 |
|
631659 |
SodiumChloride(Ph.Eur,BP,USP,JP)lowendotoxin,IPEC grade |
7647-14-5 |
|
636454 |
SodiumCaprylate(USP-NF,BP,Ph.Eur.,ChP)lowendotoxin,IPEC grade |
1984-06-1 |
Reference Materials:
· IPEC Official Website: www.ipec.org
· IPEC-PQG GMP Guidelines
· USP/EP/ChP Pharmacopoeial Standards
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