Folic Acid Impurity 16 CAS 68538-85-2
| CAS No. | 68538-85-2 |
| Molecular Formula | C20H23N7O7 |
| Molecular Weight | 473.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Folic Acid Impurity 16 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Folic Acid Impurity 16 (CAS 68538-85-2) is a certified pharmaceutical impurity reference standard with the molecular formula C20H23N7O7 and a molecular weight of 473.44 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Folic Acid Impurity 16 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 473.44 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.
As a certified reference material (CRM), Folic Acid Impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C20H23N7O7 |
| Molecular Weight | 473.44 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1976 |
| Nitrogen Atoms | 7 |
Related Folic Standards
- Folic Acid Impurity 23 (CAS 79573-48-1)
- Folic Acid Impurity 54 (CAS CATO-C4X-139554)
- Folic Acid Impurity 70 (CAS 2305206-68-0)
- Folic Acid Impurity N2 (CAS 2800-34-2)
- Folic Acid Impurity 56 (CAS CATO-C4X-139556)
- Folic Acid Impurity 35 (CAS 2311-81-1)
- Folic acid impurity 58 (CAS CATO-C4X-139558)
- Folic Acid-D5 N-Nitroso (CAS CATO-C4X-139568)
Recommended Standards
- D-Folinic acid (CAS 54353-24-1)
- (E)-4-(benzo[d][1,3]dioxol-5-yl)-2-(4-nitrostyryl)-5-oxo-5H-indeno[1,2-b]pyridine-3-carbonitrile (CAS 866142-86-1)
- (E)-4-(benzo[d][1,3]dioxol-5-yl)-2-(3-nitrostyryl)-5-oxo-5H-indeno[1,2-b]pyridine-3-carbonitrile (CAS 866136-00-7)
- Methyl 5-acetamido-4-7-8-9-tetra-O-acetyl-2-6-anhydro-3-5-dideoxy-D-glycero-D-galacto-non-2-enonate (CAS 73960-72-2)
- Empagliflozin impurity 158 (CAS 226213-72-5)
- Clindamycin Impurity 83 (CAS CATO-C4X-134183)
- Norepinephrine Impurity 91 (CAS 7760-00-1)
- 6-(3-Fluorophenyl)-5,6,7,8-tetrahydro-[1,3]dioxolo[4,5-g]quinolin-8-amine (CAS 1956326-58-1)
- (R)-1-(3-Phenyl-3H-imidazo[4,5-b]pyridin-2-yl)ethanamine (CAS 1398507-85-1)
- (4-Chlorophenyl)(3-(methoxymethoxy)phenyl)methanone (CAS 938458-70-9)
- (3,6-dimethylpyridazin-4-yl)methanol (CAS 18591-51-0)
- 4-Nitro-2-(methylsulfonyl)anisole (CAS 38063-41-1)
- 2-Amino-N-cycloheptyl-4-phenylthiazole-5-carboxamide (CAS 1175881-29-4)
- [3-31]-Semaglutide D (CAS C152H230N42O47)
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