Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
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- Chemical Name:
- Vonoprazan Impurity B-2
- Structure:
- Chemical Name:
- 2-(Cyanomethylthio)acetic acid
- CAS:
- 55817-29-3
- MF:
- C4H5NO2S
- Structure:
- Chemical Name:
- 2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)-
- CAS:
- 2437650-75-2
- MF:
- C15H19N3O2
- Structure:
- Chemical Name:
- 4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl-
- CAS:
- 2512216-37-2
- MF:
- C16H17N3O2
- Chemical Name:
- Budesonide Impurity 31
- Chemical Name:
- Budesonide Impurity 23
- Structure:
- Chemical Name:
- Hexanoic acid, 3-(chloromethyl)-, (3R)-
- CAS:
- 2101641-90-9
- MF:
- C7H13ClO2
- Structure:
- Chemical Name:
- Bisoprolol Impurity
- CAS:
- 2226263-68-7
- MF:
- C18H31NO4
- Structure:
- Chemical Name:
- 2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)-
- CAS:
- 1261219-83-3
- MF:
- C18H17NO4
- Structure:
- Chemical Name:
- Tofacitinib Impurity
- CAS:
- 2504210-41-5
- MF:
- C29H38N10O2
- Structure:
- Chemical Name:
- 2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)-
- CAS:
- 2459302-85-1
- MF:
- C21H27N7O3
- Chemical Name:
- Avatrombopag Impurity 38
- Structure:
- Chemical Name:
- (1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium)
- CAS:
- 96946-55-3
- MF:
- C53H72N2O12+2
- Structure:
- Chemical Name:
- CHLORHEXIDENE DIACETATE IMPURITY A
- CAS:
- 152504-08-0
- MF:
- C16H24ClN9
- Chemical Name:
- Fesoterodine Impurity 14
- Chemical Name:
- Dexamethasone EP impurities E
- Structure:
- Chemical Name:
- (R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide
- MF:
- C11H21BrN2O2
- Chemical Name:
- Empagliflozin Impurity 57（R,R）
- Structure:
- Chemical Name:
- Azacitidine Impurity 37
- CAS:
- 206269-46-7
- MF:
- C8H12N4O5
- Chemical Name:
- Aripiprazole peroxide degradation Impurity (MW:303Da)
- Chemical Name:
- Pramipexole Impurity Reference
- Chemical Name:
- 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+
- Structure:
- Chemical Name:
- 3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester
- CAS:
- 100688-45-7
- MF:
- C13H14O4
- Structure:
- Chemical Name:
- Acetaminophen Impurity 14
- CAS:
- 1991204-56-8
- MF:
- C16H18N2O2
- Structure:
- Chemical Name:
- Ketoconazole Impurity 7
- CAS:
- 172032-21-2
- MF:
- C11H12Cl2O3
- Chemical Name:
- Rosuvastatin Impurity 59
- Chemical Name:
- 5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
- Chemical Name:
- 5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
- Structure:
- Chemical Name:
- Losartan Impurity 12
- CAS:
- 727718-93-6
- MF:
- C22H22ClN9
- Structure:
- Chemical Name:
- benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride
- CAS:
- 1865726-28-8
- MF:
- C17H19NO4S
- Structure:
- Chemical Name:
- Glycopyrrolate Impurity 12
- CAS:
- 857353-41-4
- MF:
- C13H14O3
- Structure:
- Chemical Name:
- (4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide
- CAS:
- 4660-26-8
- MF:
- C22H22N2O8
- Chemical Name:
- Regorafenib Impurity 38
- Chemical Name:
- Cefazolin Impurity 28
- Chemical Name:
- 4-Isobutylacetophenone (Ibuprofen impurity)
- Structure:
- Chemical Name:
- Acarbose Impurity IV (JP)
- MF:
- C13H21NO7
- Structure:
- Chemical Name:
- (2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans -cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside
- CAS:
- 773899-29-9
- MF:
- C35H36O14
- Chemical Name:
- AZITHROMYCIN IMPURITY A
- Chemical Name:
- Isomer 1 of Tazobactam Impurity 3
- Chemical Name:
- Ceftiofur USP Impurity I
- Structure:
- Chemical Name:
- Aztreonam Open-Ring Impurity
- CAS:
- 102579-58-8
- MF:
- C13H19N5O9S2
- Chemical Name:
- Cephalexin Degradation Impurity A
- Chemical Name:
- Azlocillin Impurity 8
- Chemical Name:
- Pregabalin-8687（mixture of 4 isomers）
- Chemical Name:
- 7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
- Chemical Name:
- 1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one
- Chemical Name:
- (E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
- Structure:
- Chemical Name:
- Dolutegravir Impurity C
- CAS:
- 1802141-49-6
- MF:
- C22H23F2N3O5
- Structure:
- Chemical Name:
- Adefovir Dipivoxil Impurity 24
- CAS:
- 116384-58-8
- MF:
- C14H23O7PS
- Structure:
- Chemical Name:
- Dapoxetine Impurity 68
- CAS:
- 119357-48-1
- MF:
- C19H18O
- Structure:
- Chemical Name:
- Tobramycin Impurity
- CAS:
- 74501-86-3
- MF:
- C18H35N5O8
- Chemical Name:
- Peramivir Impurity 24
- Structure:
- Chemical Name:
- 2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE
- CAS:
- 79999-39-6
- MF:
- C16H18ClN5O7
- Structure:
- Chemical Name:
- Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol)
- CAS:
- 108928-81-0
- MF:
- C25H37NO4
- Structure:
- Chemical Name:
- N-[3-[3-(1-Piperidinylmethyl)phenoxy]propyl]amine
- CAS:
- 73278-98-5
- MF:
- C15H24N2O
- Structure:
- Chemical Name:
- 7,10-Bis-O-(2,2,2-trichloroethoxycarbonyl)-10-deacetylbaccatin III
- CAS:
- 95603-44-4
- MF:
- C35H38Cl6O14
- Structure:
- Chemical Name:
- 4-(3-AMino-phenyl)-Morpholin-3-one
- CAS:
- 1082495-22-4
- MF:
- C10H12N2O2
- Structure:
- Chemical Name:
- 7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one
- CAS:
- 53944-31-3
- MF:
- C14H11NO2
- Structure:
- Chemical Name:
- 2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine
- CAS:
- 612503-08-9
- MF:
- C12H11N3S
- Structure:
- Chemical Name:
- 21-Dehydro-16α-hydroxy Prednisolone
- CAS:
- 1188271-73-9
- MF:
- C21H26O6
- Structure:
- Chemical Name:
- (6α,11β)-11,20-Dihydroxy-6-Methyl-3-oxopregna-1,4,17(20)-trien-21-al
- CAS:
- 1338549-02-2
- MF:
- C22H28O4
- Structure:
- Chemical Name:
- (1R)-2-chloro-1-(3,4-difluorophenyl)-1-ethanol
- CAS:
- 1212376-05-0
- MF:
- C8H7ClF2O
- Structure:
- Chemical Name:
- 2-[[(3aR,4S,6R,6aS)-6-[7-Chloro-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]tetrahydro-2,2-dimethyl-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-ethanol
- CAS:
- 376608-75-2
- MF:
- C17H24ClN5O4S
- Structure:
- Chemical Name:
- Fluconazole IMpurity F
- MF:
- C13H12F2N6O
- Structure:
- Chemical Name:
- Erlotinib IMpurity A
- CAS:
- 1058132-82-3
- MF:
- C22H25N3O4
- Chemical Name:
- Apixaban iMpurity 5
- Structure:
- Chemical Name:
- cefaclor iMpurity C
- CAS:
- 143059-69-2
- MF:
- C15H14ClN3O4S
- Chemical Name:
- ceftazidiMe iMpurity B
- CAS:
- 1236700-64-3
- Structure:
- Chemical Name:
- pidotiMod iMpurity D
- CAS:
- 162148-15-4
- MF:
- C9H12N2O4S
- Structure:
- Chemical Name:
- Irinotecan Hydroxyl Acid
- CAS:
- 142677-15-4
- MF:
- C22H22N2O6
- Structure:
- Chemical Name:
- CyclopropanaMine, 2-(4-fluorophenyl)-(hydrochloride)(1:1),(1R,2S)-
- CAS:
- 1314324-00-9
- MF:
- C9H11ClFN
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)aMino)-5-(propylsulfinyl)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:
- 1644461-85-7
- MF:
- C23H28F2N6O5S
- Chemical Name:
- AtracuriuM IMpurity C (Mixture of DiastereoMers)
- CAS:
- 86293-35-8
- Chemical Name:
- AtracuriuM IMpurity E (cis-Quaternary Acid)
- Chemical Name:
- AztreonaM IMpurity B
- Chemical Name:
- AlviMopan iMpurity
- Chemical Name:
- Caspofungin iMpurity
- Structure:
- Chemical Name:
- Saxagliptin iMpurity
- CAS:
- 2173146-35-3
- MF:
- C18H24ClN3O2
- Structure:
- Chemical Name:
- Chlorocriptine
- CAS:
- 68944-88-7
- MF:
- C32H40ClN5O5
- Structure:
- Chemical Name:
- PD 312237
- CAS:
- 501666-23-5
- MF:
- C20H35NO11
- Structure:
- Chemical Name:
- (1R,5S,6S)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Methyl Ester
- CAS:
- 1234858-94-6
- MF:
- C13H20O4
- Structure:
- Chemical Name:
- 2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride
- CAS:
- 857170-72-0
- MF:
- C14H23ClN2O
- Structure:
- Chemical Name:
- 4-Hydroxy Darunavir
- CAS:
- 313682-97-2
- MF:
- C27H37N3O8S
- Structure:
- Chemical Name:
- Deschloroaripiprazole
- CAS:
- 203395-81-7
- MF:
- C23H28ClN3O2
- Structure:
- Chemical Name:
- O-[(Guanin-9-yl)Methyl] Acyclovir
- CAS:
- 166762-90-9
- MF:
- C14H16N10O4
- Structure:
- Chemical Name:
- (S)-IsotiMolol (TiMolol IMpurity B)
- CAS:
- 158636-96-5
- MF:
- C13H24N4O3S
- Chemical Name:
- Afatinib IMpurity A
- Chemical Name:
- Afatinib IMpurity G
- Chemical Name:
- Articaine IMpurity F (Articaine Acid PropionaMide HCl)
- Structure:
- Chemical Name:
- Avanafil iMpurity 4
- CAS:
- 874482-97-0
- MF:
- C8H11Cl2NO
- Structure:
- Chemical Name:
- Clopidogrel IMpurity 4
- CAS:
- 801319-16-4
- MF:
- C15H14ClNO2S
- Structure:
- Chemical Name:
- Dehydro Azelnidipine
- CAS:
- 918659-10-6
- MF:
- C33H32N4O6
- Structure:
- Chemical Name:
- DiazepaM IMpurity F
- CAS:
- 31269-33-7
- MF:
- C16H13ClN2O
- Chemical Name:
- LaMotrigine IMpurity
- Structure:
- Chemical Name:
- Demethylagrimonolide 6-O-glucoside
- CAS:
- 1257408-55-1
- MF:
- C23H26O10
- Chemical Name:
- Vonoprazan Impurity 57
- Structure:
- Chemical Name:
- Tafluprost Impurity 9
- CAS:
- 2099033-66-4
- MF:
- C27H41NO8