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.
- Structure:

- Chemical Name:Tofacitinib Related Compound
- CAS:1206824-85-2
- MF:C10H18ClN3O
- Structure:

- Chemical Name:Fluvastatin EP impurity A -G
- CAS:93957-58-5
- MF:C24H26FNO4
- Structure:

- Chemical Name:PWKRNMKZGWGSDV-UHFFFAOYSA-N
- CAS:1422960-88-0
- MF:C33H34ClN4+
- Structure:

- Chemical Name:1-(chloromethyl)-2-trifluoromethyl-4-methylbenzene
- CAS:1261456-37-4
- MF:C9H8ClF3
- Structure:

- Chemical Name:Epalrestat iMpurity
- CAS:109801-00-5
- MF:C13H18O
- Structure:

- Chemical Name:5-Oxo Pitavastatin
- CAS:222306-15-2
- MF:C25H22FNO4
- Structure:

- Chemical Name:(3R)-2,3-Dihydro-3-(2-propyn-1-ylaMino)-1H-inden-1-one
- CAS:1312077-05-6
- MF:C12H11NO
- Structure:

- Chemical Name:1-[[2'-(AMinoiMinoMethyl)[1,1'-biphenyl]-4-yl]Methyl]-2-ethoxy-1H-benziMidazole-7-carboxylic Acid
- CAS:1442400-65-8
- MF:C24H22N4O3
- Structure:

- Chemical Name:2-Hydroxy Cephalexin
- CAS:215172-75-1
- MF:C16H17N3O5S
- Structure:

- Chemical Name:3-(9H-Carbazol-4-yloxy)-1,2-propanediol
- CAS:123119-89-1
- MF:C15H15NO3
- Structure:

- Chemical Name:4-(2-Methylpropoxy)-1,3-benzenedicarbothioaMide
- CAS:1330632-46-6
- MF:C12H16N2OS2
- Structure:

- Chemical Name:8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide
- CAS:795313-24-5
- MF:C14H19BrCl2N2
- Structure:

- Chemical Name:8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide
- CAS:795313-24-5
- MF:C14H19BrCl2N2
- Structure:

- Chemical Name:9-MethoxyMethyl Guanine
- CAS:1202645-50-8
- MF:C7H9N5O2
- Structure:

- Chemical Name:ClindaMycin 3-PalMitate
- CAS:68225-59-2
- MF:C34H63ClN2O6S
- Structure:

- Chemical Name:EltroMbopag Methyl Ester
- CAS:1246929-01-0
- MF:C26H24N4O4
- Structure:

- Chemical Name:ErythroMycin A 6,9-IMino Ether
- CAS:99290-97-8
- MF:C37H66N2O12
- Structure:

- Chemical Name:α,α'-Bis[(2-Methoxyphenoxy)Methyl]-1,4-piperazinediethanol
- CAS:333749-57-8
- MF:C24H34N2O6
- Structure:

- Chemical Name:Ticagrelor IMpurity E
- CAS:1402150-34-8
- MF:C26H30F2N6O5S
- Structure:

- Chemical Name:Benzenebutanoicacid,b-[[(1,1-diMethylethoxy)carbonyl]aMino]-2,4,5-trifluoro-,Methylester,(bR)-
- CAS:881995-73-9
- MF:C16H20F3NO4
- Structure:

- Chemical Name:Bosutinib Impurity 1
- CAS:1460227-29-5
- MF:C18H13Cl2N3O3
- Structure:

- Chemical Name:tert-butyl 4-cyclohexylpiperazine-1-carboxylate
- CAS:1224935-95-8
- MF:C15H28N2O2
- Structure:

- Chemical Name:2-Debenzoyl-2-pentenoyl Docetaxel
- CAS:1412898-66-8
- MF:C41H55NO14
- Chemical Name:Afatinib IMpurity D
- CAS:
- MF:
- Chemical Name:Afatinib IMpurity D
- CAS:
- MF:
- Structure:

- Chemical Name:Avanafil iMpurity 1
- CAS:372117-54-9
- MF:C18H22ClN5O3
- Structure:

- Chemical Name:Bisoprolol EP IMpurity B HeMifuMarate (Bisoprolol n-Propyl Derivative HeMifuMarate)
- CAS:1447715-44-7
- MF:C18H31NO4
- Structure:

- Chemical Name:Dabigatran iMpurity F
- CAS:1642853-67-5
- MF:C19H20N4O4
- Structure:

- Chemical Name:Decitabine iMpurity 4
- CAS:863396-35-4
- MF:C6H12O4
- Structure:

- Chemical Name:Gliclazide iMpurity D
- CAS:1136426-19-1
- MF:C15H20N2O3S
- Structure:

- Chemical Name:Losartan IMpurity C (Isolosartan)
- CAS:114799-13-2
- MF:C22H23ClN6O
- Structure:

- Chemical Name:Posaconazole DiastereoisoMer interMediate 2
- CAS:166583-12-6
- MF:C21H21F2N3O4S
- Structure:

- Chemical Name:Quetiapine IMpurity P (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine fuMarate))
- CAS:1011758-03-4
- MF:C19H21N3S
- Structure:

- Chemical Name:TaMsulosin IMpurity B
- CAS:
- MF:C20H28N2O5S
- Chemical Name:Ticagrelor iMpurity N
- CAS:
- MF:
- Structure:

- Chemical Name:Tirofiban IMpurity (4,4'-Dipyridyl-1,5-Pentane)
- CAS:25382-33-6
- MF:C15H18N2
- Structure:

- Chemical Name:3-Quinolinecarbonitrile,4-chloro-6-Methoxy-7-[3-(4-Methyl-1-piperazinyl)propoxy]-
- CAS:492444-39-0
- MF:C19H23ClN4O2
- Structure:

- Chemical Name:Vardenafil Oxopiperazine (IMpurity)
- CAS:448184-58-5
- MF:C21H26N6O5S
- Structure:

- Chemical Name:IverMectin B1 Aglycon
- CAS:73162-95-5
- MF:C34H50O8
- Structure:

- Chemical Name:9α-BroMobudesonide
- CAS:313474-59-8
- MF:C25H33BrO6
- Structure:

- Chemical Name:N-(5-Chloro-2-pyridinyl)-2-pyrazinecarboxaMide (Zopiclone IMpurity)
- CAS:349125-10-6
- MF:C10H7ClN4O
- Structure:

- Chemical Name:22,23-Didehydro SelaMectin
- CAS:165108-09-8
- MF:C43H61NO11
- Structure:

- Chemical Name:2-Methyl SiMvastatin (Mixture Of DiasteroisoMers)
- CAS:774611-54-0
- MF:C26H40O5
- Structure:

- Chemical Name:(4-Chloro-3,5-diMethylpyridin-2-yl)Methanol Hydrochloride
- CAS:143016-70-0
- MF:C8H11Cl2NO
- Structure:

- Chemical Name:AMoxicillin DiMer (penicilloic acid forM)
- CAS:210289-72-8
- MF:C32H40N6O11S2
- Structure:

- Chemical Name:AMoxicillin DiMer (penicilloic acid forM)
- CAS:210289-72-8
- MF:C32H40N6O11S2
- Structure:

- Chemical Name:Desacetyl-7-ACA Lactone
- CAS:184696-69-3
- MF:C8H8N2O3S
- Structure:

- Chemical Name:5,6-DiMethoxy-2-[(4-piperidyl)Methyl]indane Hydrochloride (Donepezil IMpurity)
- CAS:1034439-43-4
- MF:C17H26ClNO2
- Structure:

- Chemical Name:CarfilzoMib IMpurity
- CAS:1541171-65-6
- MF:C41H61N5O10S
- Structure:

- Chemical Name:S,S-Efinaconazole
- CAS:164650-45-7
- MF:C18H22F2N4O
- Chemical Name:BendaMustine IMpurity
- CAS:
- MF:
- Structure:

- Chemical Name:Acetic acid, 2-chloro-2-[2-(2-Methoxyphenyl)hydrazinylidene]-, ethyl ester
- CAS:85014-68-2
- MF:C11H13ClN2O3
- Structure:

- Chemical Name:D-Alanine, N-[[P(S),2'R]-2'-cyano-2'-deoxy-2'-Methyl-P-phenyl-5'-cytidylyl]-, 1-Methylethyl ester
- CAS:1496552-28-3
- MF:C22H29FN3O9P
- Structure:

- Chemical Name:D-Glucitol, 1,5-anhydro-1-C-[4-Methyl-3-[(5-phenyl-2-thienyl)Methyl]phenyl]-, (1S)-
- CAS:842133-16-8
- MF:C24H26O5S
- Structure:

- Chemical Name:Phthalic acid, 3,3'-azoxydi- (8CI)
- CAS:22895-28-9
- MF:C16H10N2O9
- Structure:

- Chemical Name:(alphaE)-alpha-[(3,4-Dihydroxy-5-nitrophenyl)methylene]-beta-oxo-1-piperidinepropanenitrile
- CAS:1150310-15-8
- MF:C15H15N3O5
- Structure:

- Chemical Name:(2E)-2-Cyano-3-(3-ethoxy-4-hydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide
- CAS:857629-79-9
- MF:C16H19N3O5
- Structure:

- Chemical Name:(R)-3-((S)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:404874-94-8
- MF:C20H20FNO4
- Structure:

- Chemical Name:(S)-3-((S)-5-hydroxy-5-phenylpentanoyl)-4-phenyloxazolidin-2-one
- CAS:
- MF:C20H21NO4
- Structure:

- Chemical Name:Apixaban Impurity 20
- CAS:1421823-20-2
- MF:C27H29ClN4O5
- Structure:

- Chemical Name:Posaconazole iMpurity 4
- CAS:2125944-53-6
- MF:C30H35N5O3
- Structure:

- Chemical Name:Everolimus Ring-Opening Impurity
- CAS:1708118-13-1
- MF:C53H83NO14
- Structure:

- Chemical Name:Topiroxostat Impurity 6
- CAS:2044704-63-2
- MF:C7H8N4O2
- Structure:

- Chemical Name:Dienogest Impurity I
- CAS:65928-65-6
- MF:C20H27NO2
- Structure:

- Chemical Name:Febuxostat Impurity 8
- CAS:144060-62-8
- MF:C16H17NO4S
- Structure:

- Chemical Name:Lornoxicam Impurity 9
- CAS:70374-36-6
- MF:C6H6ClNO4S2
- Structure:

- Chemical Name:Ticagrelor Related Compound 3
- CAS:88756-83-6
- MF:C8H15NO3
- Structure:

- Chemical Name:135270-10-9
- CAS:135270-10-9
- MF:C12H11F2N3O
- Structure:

- Chemical Name:Tadalafil EP Impurity
- CAS:479545-76-1
- MF:C21H16N2O5
- Chemical Name:Vonoprazan Impurity C
- CAS:
- MF:
- Structure:

- Chemical Name:(5RS)-5-Ethyl-2,6-diimino-5-phenyl-1,2,5,6-tetrahydropyrimidin-4(3H)-one
- CAS:69125-70-8
- MF:C12H14N4O
- Structure:

- Chemical Name:4-(benzyloxy)-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid
- CAS:942195-83-7
- MF:C16H14N2O3
- Chemical Name:Tofacitinib Impurity G
- CAS:
- MF:
- Structure:

- Chemical Name:Ceftaroline Fosamil Impurity 6
- CAS:953037-71-3
- MF:C22H20N8O5S4
- Structure:

- Chemical Name:Zolmitriptan Related Compound F
- CAS:1350928-05-0
- MF:C38H53N7O4
- Structure:

- Chemical Name:4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butan-1-ol
- CAS:913614-15-0
- MF:C16H22N2OS
- Structure:

- Chemical Name:3-((methoxycarbonyl)methyl)-5-methylhexanoic acid
- CAS:181289-11-2
- MF:C10H18O4
- Structure:

- Chemical Name:Cyanocobalamin Impurity F
- CAS:23208-66-4
- MF:C63H85CoN13O15P
- Chemical Name:Acarbose Impurity D
- CAS:
- MF:
- Chemical Name:Acarbose Impurity D
- CAS:
- MF:
- Chemical Name:Acarbose Impurity C
- CAS:
- MF:
- Chemical Name:Acarbose Impurity C
- CAS:
- MF:
- Chemical Name:Nintedanib Impurity G (Intedanib Impurity G)
- CAS:
- MF:
- Chemical Name:Canagliflozin alpha-Isomer Impurity
- CAS:
- MF:
- Chemical Name:Dapagliflozin Impurity 4
- CAS:960404-50-6
- MF:
- Chemical Name:Isavuconazole Impurity 9
- CAS:
- MF:
- Chemical Name:Apremilast Impurity E
- CAS:
- MF:
- Structure:

- Chemical Name:Bisoprolol EP Impurity N
- CAS:1346601-75-9
- MF:C17H29NO4
- Chemical Name:Rosuvastatin EP Impurity J
- CAS:
- MF:
- Structure:

- Chemical Name:Bosutinib Impurity
- CAS:380843-12-9
- MF:C19H15Cl2N3O3
- Structure:

- Chemical Name:4-(4-Chloro-pyrimidin-2-ylamino)-benzamide
- CAS:1629023-90-0
- MF:C18H12N6
- Structure:

- Chemical Name:Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate
- CAS:488798-36-3
- MF:C15H17FN2O3
- Structure:

- Chemical Name:Nateglinide Methyl Ester
- CAS:105746-47-2
- MF:C20H29NO3
- Structure:

- Chemical Name:(1S,2S,3R,5S)-3-(5-Amino-6-chloro-2-(propylthio)pyrimidin-4-ylamino)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:1402150-32-6
- MF:C14H23ClN4O4S
- Structure:

- Chemical Name:Lamivudine impurity 6
- CAS:147126-64-5
- MF:C14H24O4S
- Chemical Name:Palbociclib Impurity G
- CAS:
- MF:
- Chemical Name:Trifluridine Impurity 1
- CAS:
- MF:
- Structure:

- Chemical Name:Tigecycline Impurity 1
- CAS:1138343-10-8
- MF:C29H38N5O10+
- Structure:

- Chemical Name:Cephalexin Impurity 3
- CAS:
- MF:C16H17N3O4S
- Chemical Name:Vonoprazan Impurity 2
- CAS:
- MF: