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Old Friend, New Look – Introduction to AppliChem IPEC-Grade Products

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.


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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