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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- Structure:
- Chemical Name:
- Tolterodine Lactol IMpurity
- CAS:
- 209747-04-6
- MF:
- C16H16O2
- Chemical Name:
- Valsartan N1-Trityl IMpurity
- Structure:
- Chemical Name:
- (3-Carbamoylallyl)trimethylammonium
- CAS:
- 857162-57-3
- MF:
- C7H15N2O+
- Structure:
- Chemical Name:
- 3-CHLORO-4-HYDROXYACETANILIDE
- CAS:
- 3964-54-3
- MF:
- C8H8ClNO2
- Chemical Name:
- Apixaban IMpurity(BMS-591329-01)
- Structure:
- Chemical Name:
- ent-14S-3-Methoxy-17-MethylMorphinan
- CAS:
- 1453167-99-1
- MF:
- C18H25NO
- Structure:
- Chemical Name:
- PD 224378
- CAS:
- 501665-88-9
- MF:
- C20H35NO11
- Structure:
- Chemical Name:
- (rac,syn)-4-Deschloro-sertraline
- CAS:
- 871838-58-3
- MF:
- C17H18ClN
- Structure:
- Chemical Name:
- 1-[2-(DiMethylaMino)-1-phenylethyl]cyclohexanol
- CAS:
- 93413-86-6
- MF:
- C16H25NO
- Structure:
- Chemical Name:
- 1-[4-(2-Methoxyethenyl)phenoxy]-3-[(1-Methylethyl)aMino]-2-propanol
- CAS:
- 82961-02-2
- MF:
- C15H23NO3
- Structure:
- Chemical Name:
- 11-Desethyl Irinotecan
- CAS:
- 103816-16-6
- MF:
- C31H34N4O6
- Structure:
- Chemical Name:
- 5-Methoxy-2-[[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]thio]-1H-benziMidazole N-Oxide
- CAS:
- 142885-92-5
- MF:
- C17H19N3O3S
- Structure:
- Chemical Name:
- 7-[[[(CyanoMethyl)thio]acetyl]aMino]-7-Methoxy Cephalosporanic Acid
- CAS:
- 56796-16-8
- MF:
- C15H17N3O7S2
- Structure:
- Chemical Name:
- 7S-Cefdinir
- CAS:
- 178601-89-3
- MF:
- C14H13N5O5S2
- Structure:
- Chemical Name:
- Dehydroxy BroMocelecoxib
- CAS:
- 170570-75-9
- MF:
- C17H13BrF3N3O2S
- Structure:
- Chemical Name:
- Desethylene Norfloxacin Hydrochloride
- CAS:
- 75001-77-3
- MF:
- C14H16FN3O3
- Structure:
- Chemical Name:
- p-(2,3-Epoxypropoxy)benzyl Alcohol
- CAS:
- 4204-78-8
- MF:
- C10H12O3
- Structure:
- Chemical Name:
- α-Etoposide
- CAS:
- 100007-53-2
- MF:
- C29H32O13
- Structure:
- Chemical Name:
- N-Desmethyl-N-benzyl Sildenafil
- CAS:
- 1446089-82-2
- MF:
- C28H34N6O4S
- Structure:
- Chemical Name:
- 4-Hydroxy AtoMoxetine Oxalate
- CAS:
- 457634-21-8
- MF:
- C19H23NO6
- Structure:
- Chemical Name:
- 6-Chloro-1-Ethyl-4-Oxo-7-(Piperazin-1-yl)-1,4-Dihydroquinoline-3-Carboxylic acid
- CAS:
- 67681-84-9
- MF:
- C16H18ClN3O3
- Structure:
- Chemical Name:
- Afatinib IMpurity J
- CAS:
- 1456696-14-2
- MF:
- C18H22N4O4
- Chemical Name:
- Aprepitant iMpurity A
- Structure:
- Chemical Name:
- Atorvastatin LactaM Phenanthrene CalciuM Salt
- CAS:
- 1046378-58-8
- MF:
- C33H35CaFN2O6
- Chemical Name:
- Avanafil IMpurity 7
- Structure:
- Chemical Name:
- Desfluoro flurbiprofen axetil
- CAS:
- 1685278-08-3
- MF:
- C19H20O4
- Structure:
- Chemical Name:
- Desloratadine IMpurity 6
- CAS:
- 38092-90-9
- MF:
- C20H21ClN2
- Chemical Name:
- ErtapeneM Ring Open IMpurity
- Chemical Name:
- LincoMycin iMpurity C
- Chemical Name:
- Norfloxacin iMpurity E
- Chemical Name:
- Posaconazole iMpurity 2
- Structure:
- Chemical Name:
- Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol]
- CAS:
- 2206135-50-2
- MF:
- C25H18N2S2
- Chemical Name:
- Rabeprazole iMpurity (Chloro interMediate)
- Structure:
- Chemical Name:
- TaMsulosin IMpurity F
- MF:
- C20H28N2O5S
- Structure:
- Chemical Name:
- TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin)
- CAS:
- 113323-39-0
- MF:
- C28H45NO4S
- Structure:
- Chemical Name:
- 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol
- CAS:
- 848814-27-7
- MF:
- C21H27N3O3S
- Structure:
- Chemical Name:
- (3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester
- CAS:
- 204254-90-0
- MF:
- C15H24O7S
- Structure:
- Chemical Name:
- TorseMide Carboxylic Acid
- CAS:
- 113844-99-8
- MF:
- C16H18N4O5S
- Structure:
- Chemical Name:
- (3S,5R)-Fluvastatin SodiuM Salt
- CAS:
- 94061-81-1
- MF:
- C24H25FNNaO4
- Structure:
- Chemical Name:
- (6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone
- CAS:
- 1402819-05-9
- MF:
- C17H11Br3O3
- Structure:
- Chemical Name:
- Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate
- CAS:
- 202534-94-9
- MF:
- C15H16FNO4
- Chemical Name:
- Tofacitinib Impurity H
- Structure:
- Chemical Name:
- 3',6'-Dehydroclindamycin
- CAS:
- 1440605-51-5
- MF:
- C18H31ClN2O5S
- Structure:
- Chemical Name:
- Iguratimod Impurity 5
- CAS:
- 84594-95-6
- MF:
- C13H11NO4
- Chemical Name:
- Cefradine Impurity F
- Structure:
- Chemical Name:
- Mirabegron Impurity
- CAS:
- 1684452-83-2
- MF:
- C26H28N6O3S2
- Structure:
- Chemical Name:
- 1-methyl-1H-indol-6-ol
- CAS:
- 130570-60-4
- MF:
- C9H9NO
- Structure:
- Chemical Name:
- 2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester
- CAS:
- 118485-48-6
- MF:
- C13H13NO3S
- Structure:
- Chemical Name:
- 32-Carboxycyanocobalamin
- CAS:
- 121483-62-3
- MF:
- C63H87CoN13O15P
- Chemical Name:
- Alvimopan Impurity 6
- Chemical Name:
- Acarbose Impurity B
- Chemical Name:
- Sofosbuvir Impurity28
- Chemical Name:
- Rivaroxaban Impurity 10
- Chemical Name:
- Ipragliflozin Impurity 1
- Chemical Name:
- EMpagliflozin iMpurity 8
- Structure:
- Chemical Name:
- EMpagliflozin iMpurity 13
- CAS:
- 2125472-55-9
- MF:
- C23H25ClO8
- Structure:
- Chemical Name:
- 6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole))
- CAS:
- 1365727-07-6
- MF:
- C27H26N2O2
- Structure:
- Chemical Name:
- ETHYL 3,4-EPOXYBUTANOATE
- CAS:
- 32223-97-5
- MF:
- C6H10O3
- Structure:
- Chemical Name:
- (2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid
- CAS:
- 1012341-56-8
- MF:
- C23H29NO4
- Chemical Name:
- Alogliptin Impurity A
- Structure:
- Chemical Name:
- Linagliptin Impurity D
- CAS:
- 666816-91-7
- MF:
- C20H28N6O4
- Chemical Name:
- Parecoxib Impurity C
- Structure:
- Chemical Name:
- (17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
- CAS:
- 98149-13-4
- MF:
- C20H24BrNO2
- Structure:
- Chemical Name:
- 316173-27-0
- CAS:
- 316173-27-0
- MF:
- C17H28N2O5
- Structure:
- Chemical Name:
- Azilsartan Impurity
- CAS:
- 1821386-21-3
- MF:
- C22H18N4O4
- Structure:
- Chemical Name:
- Irbesartan impurity 7
- MF:
- C25H28N6O
- Chemical Name:
- Voriconazole Impurity 2
- Chemical Name:
- Safinamide Impurity 1
- Chemical Name:
- Caspofungin impurit 2
- Chemical Name:
- Lamivudine impurity 1
- Structure:
- Chemical Name:
- Raltitrexed Impurity 1
- CAS:
- 1378372-01-0
- MF:
- C10H10N2O2
- Structure:
- Chemical Name:
- Loratadine Impurity 6
- MF:
- C22H23ClN2O2
- Chemical Name:
- Mirabegron Impurity 3
- Chemical Name:
- Plerixafor Impurity C
- Chemical Name:
- Vonoprazan Impuirty 8
- Chemical Name:
- Sitagliptin IMpurity 4
- Chemical Name:
- Brexpiprazole Impurity1
- Chemical Name:
- Acarbose Impurity E
- Structure:
- Chemical Name:
- Alvimopan Impurity 1
- CAS:
- 2250243-53-7
- MF:
- C14H19NO
- Chemical Name:
- Febuxostat Impurity A
- Structure:
- Chemical Name:
- Fingolimod Hexyl Impurity
- CAS:
- 1201794-93-5
- MF:
- C17H29NO2
- Chemical Name:
- Palbociclib Impurity 1
- Chemical Name:
- Trelagliptin Impurity 8
- Structure:
- Chemical Name:
- Bromhexine Impurity H
- CAS:
- 63471-27-2
- MF:
- C14H21BrN2
- Structure:
- Chemical Name:
- Apixaban Impurity 17
- CAS:
- 1423803-24-0
- MF:
- C20H19N5O3
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 11
- CAS:
- 1411775-06-8
- MF:
- C14H17N3O4
- Structure:
- Chemical Name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate
- MF:
- C25H35NO3
- Chemical Name:
- Flomoxef Impurity 4
- Chemical Name:
- Nicardipine Impurity 5
- Structure:
- Chemical Name:
- 11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE
- CAS:
- 263366-81-0
- MF:
- C30H24Cl2N6
- Structure:
- Chemical Name:
- Sacubitril Impurity 7
- CAS:
- 149709-44-4
- MF:
- C22H25NO5
- Structure:
- Chemical Name:
- Valsartan Impurity 5
- CAS:
- 1266616-11-8
- MF:
- C18H21N5
- Structure:
- Chemical Name:
- 3-Hydroxy Agomelatine
- CAS:
- 166526-99-4
- MF:
- C15H17NO3
- Structure:
- Chemical Name:
- Milnacipran Impurity 4
- CAS:
- 1353644-49-1
- MF:
- C15H21NO2
- Structure:
- Chemical Name:
- (3S,5R)-Atorvastatin
- CAS:
- 887324-52-9
- MF:
- C33H35FN2O5
- Structure:
- Chemical Name:
- Heptyl Deoctyl Fingolimod Hydrochloride
- CAS:
- 745767-97-9
- MF:
- C18H31NO2
- Structure:
- Chemical Name:
- Tenofovir Fumarate
- CAS:
- 1246812-23-6
- MF:
- C21H34N5O9P
- Structure:
- Chemical Name:
- Prucalopride Impurity C
- CAS:
- 1599434-55-5
- MF:
- C17H24ClN3O3
- Structure:
- Chemical Name:
- 1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- CAS:
- 2205053-60-5
- MF:
- C21H24FN3O4
- Structure:
- Chemical Name:
- Brexpiprazole N-Oxide
- CAS:
- 1191900-58-9
- MF:
- C25H27N3O3S