| CAS No. | CATO-C4X-209544 |
| Molecular Formula | C12H14O9 |
| Molecular Weight | 302.23 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Glucose Impurity 44.
CATO supplies Glucose Impurity 44 (CAS CATO-C4X-209544), a pharmacopoeial impurity reference standard (molecular formula C12H14O9, MW 302.23 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Glucose Impurity 44 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 302.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
CATO manufactures Glucose Impurity 44 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | C12H14O9 |
| Molecular Weight | 302.23 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |