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Alendronate impurities and related standards

Alendronate is held here as a working collection of 14 reference materials across 6 CAS numbers. Within the range, 1 EP-designated impurities are named explicitly. 5 of the entries are impurity-type materials of the parent, 7 are salt or counter-ion variants and 3 carry a deuterium label. 6 entries carry a verified structure drawing, a coverage of 43%; the rest are listed without a structure rather than with an unverified one. 6 of them sit in tier A or B, meaning the data behind the page is complete enough to be indexed and quoted directly, while 8 remain tier C and are kept for search coverage. Isotopically labelled standards are judged on the distribution rather than on a single purity number, because a material that is 99 per cent pure chemically can still carry a substantial unlabelled fraction, and that fraction is what biases a quantitative assay. For a laboratory setting specifications, the workable sequence is to fix the impurity list from the monograph and the degradation study first, and only then to source the standards, because the list determines which materials are worth holding.

Sources: DailyMed (US NLM) - ALENDRONATE (ALENDRONATE SODIUM TABLET) TABLET [MARLEX PHARMACEUTICALS, INC.].

6 reference standards related to Alendronate held in the RSSE catalogue — pharmacopoeial impurities, non-compendial impurities, metabolites and labelled analogues where available.

In this group: 2 stable isotope labelled standards · 2 fine chemicals · 1 impurity reference standard · 1 api reference standard. CAS numbers are listed for 6 of 6; 6 entries carry a structure drawing.

On this page

6 reference standards

All entries — structure, identifiers and pack sizes

6 reference standards

Frequently asked

How many Alendronate-related reference standards do you hold?
6 standards are listed on this page as of the latest catalogue build. CAS numbers are published for 6 of them and 6 entries carry a structure drawing. The catalogue is extended as new lots are released.
Can you supply an Alendronate impurity that is not listed here?
Yes. Non-compendial impurities can be quoted from a structure — a CAS number is not required. Send the structure, a SMILES string or the parent drug substance with your enquiry and we will come back with availability.
What documentation is supplied with Alendronate impurities?
Every lot ships with its own certificate of analysis. The certificate records the catalogue number, the batch number, the tests performed, the specification applied and the result obtained for that lot. A safety data sheet is supplied with the shipment.
Do you publish prices or a lead time for Alendronate impurities?
No price list is published: quotations are prepared per enquiry, because availability and packing depend on the lot and the quantity you need. Send the catalogue number and the quantity and a technical contact will answer with availability and a quotation.

Cannot find the impurity you need? Non-compendial impurities can be quoted from a structure — a CAS number is not required. Write to sales@rssechem.com.