Reference Standards

Reference Standards are standard substances used for the identification, testing, and assay of pharmaceuticals, and serve as a crucial benchmark for measuring pharmaceutical quality through chemical methods.

Imported reference standards refer to current-lot standard substances included and supplied by international pharmacopoeias or national pharmacopoeial authorities, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (EP). They feature reliable quality, can be used directly without calibration, and can act as primary reference materials for calibrating working reference standards.

In accordance with current GMP (Good Manufacturing Practice) pharmaceutical guidelines, reference standards must be procured from legally recognized authorities (e.g., USP, BP, EP) or qualified secondary suppliers.

To help users obtain imported reference standards more conveniently and efficiently, XMJ Sci officially launches the procurement service for United States Pharmacopeia (USP) and European Pharmacopoeia (EP) reference standards. This service helps you streamline the cumbersome order placement and import procedures, reduce labor and time costs, and truly achieve cost reduction and efficiency improvement!

United States Pharmacopeial Convention (USP)

The United States Pharmacopeial Convention (USP) is a non-profit scientific organization that establishes standards for the quality, purity, identification, and strength of pharmaceuticals, food ingredients, and dietary supplements manufactured, distributed, and used worldwide. USP standards are enforced by the U.S. Food and Drug Administration (FDA) in the United States, and these standards are also developed and adopted in more than 130 countries and regions around the world.

USP Reference Standards are reference materials produced by the United States Pharmacopeia (USP) to set quality standards for prescription and over-the-counter (OTC) drugs, dietary supplements, and other healthcare products. They are fully standardized samples of active pharmaceutical ingredients (APIs), excipients, key impurities, degradation products, and samples for performance calibration. These standards are mainly used for testing in accordance with USP standard methods.

USP Main Product:

USP Reference Standards

Product Catalog:

https://store.usp.org/reference-standards/

Documents Provided with Goods:

USP Certificate, Material Safety Data Sheet (MSDS)

European Pharmacopoeia (EP)

The European Pharmacopoeia, abbreviated as EP, is the guarantee for the quality and reliability of pharmaceuticals in the European Union (EU). Laboratories of the European Directorate for the Quality of Medicines & HealthCare (EDQM) select and inspect reference standard batches and their preparation in accordance with the theoretical methods specified in the EP, and the official reports thereof are approved by the European Pharmacopoeia Commission.

EDQM Reference Materials are specially screened, and the reference materials undergo verification by the European Pharmacopoeia Commission after testing. Depending on the intended use of the reference materials (e.g., identification, purity testing, assay), they may be used as items for international collaborative studies. The establishment and distribution of these reference materials are conducted in compliance with the fundamental principles of ISO Guide 34. These reference materials can be used as reference standards in pharmaceutical analysis such as identification tests, related substances testing, and assay, and can also be used for instrument calibration. EDQM has been designated as the collaborative calibration center for WHO International Reference Standards for Antibiotics.

Main Product:

European Pharmacopoeia (EP) Reference Standards

Product Catalog:

https://crs.edqm.eu/

Documents Provided with Goods:

Safety Data Sheet (SDS), Certificate of Origin (Origin of Goods)

Beijing XMJ Scientific Co., Ltd.

Beijing XMJ Scientific Co., Ltd. (hereinafter referred to as "XMJ Sci") was founded in 2006 by professionals in the biological field who returned to China after studying in the United States. It is a high-tech company integrating the sales of imported reagents, technical services, and contract development, aiming to provide first-class products and services for the development of life sciences.

Over the 19 years since its establishment, XMJ Sci has diligently and practically integrated high-quality global resources, providing customers with a wide range of professional products and services. These include basic components of cell culture media, GMP-grade transfection reagents, various pharmacopoeia-grade biochemical reagents, purification resins, GMP-grade nucleases, HCP/HCD detection kits, detection kits for bioprocess impurity residues (such as Protein A, BSA, and MVM), CE-SDS protein analysis kits, injectable pharmaceutical excipients, antigens/antibodies/substrates, as well as HCP antibody coverage verification and custom kit development services. These offerings meet the one-stop needs from R&D to production, covering cell culture, transfection, purification processes, quality control, formulation, and drug evaluation.

XMJ Sci holds import and export qualifications and has its own international logistics system. It has established long-term and stable cooperative relationships with more than 40 domestic and foreign suppliers of reagents, instruments, raw materials, auxiliary materials, and technical services, bringing together dozens of well-known domestic and foreign brands such as Applichem, Cygnus, Pfanstiehl, c-LEcta, Mirus, Astrea Bioseparations, LGC-KPL, USP, EDQM, and Zhoufan Biology.

With the development of its business, XMJ Sci has successively established branches in Shanghai, Guangzhou, Chengdu, Wuhan and other cities. It has become a designated supplier for the procurement platforms of domestic biopharmaceutical enterprises, diagnostic companies, well-known multinational pharmaceutical companies, as well as major universities and research institutions, winning the support and trust of numerous customers.