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:
- Cefuroxime Sodium EP Impurity C
- CAS:
- 69822-88-4
- MF:
- C15H15N3O6S
- Structure:
- Chemical Name:
- Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid
- CAS:
- 76812-49-2
- MF:
- C23H20ClNO8
- Structure:
- Chemical Name:
- Cefuroxime Sodium EP Impurity G
- CAS:
- 97232-98-9
- MF:
- C17H17N3O8S
- Structure:
- Chemical Name:
- 2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone
- CAS:
- 1244949-62-9
- MF:
- C11H14ClN3O
- Structure:
- Chemical Name:
- Cetirizine 3-Chloro Impurity
- CAS:
- 1232460-31-9
- MF:
- C21H25ClN2O3
- Structure:
- Chemical Name:
- Donepezil Impurity 8
- CAS:
- 1808997-65-0
- MF:
- C18H23NO4
- Chemical Name:
- Rivaroxaban Impurity 23
- Structure:
- Chemical Name:
- (Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide
- CAS:
- 1450758-21-0
- MF:
- C5H6N4O2S
- Structure:
- Chemical Name:
- Fosfomycin Trometamol impurity C
- CAS:
- 23001-39-0
- MF:
- C4H12NO6P
- Structure:
- Chemical Name:
- (R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate
- MF:
- C22H23FN2O5
- Structure:
- Chemical Name:
- 1-(Isopropylamino)-3-(4-methylphenoxy)propane-2-ol
- CAS:
- 5790-46-5
- MF:
- C13H21NO2
- Structure:
- Chemical Name:
- 5H-Dibenz[b,f]azepine-10,11-dione
- CAS:
- 19579-83-0
- MF:
- C14H9NO2
- Structure:
- Chemical Name:
- Ethanesulfonic acid ethyl ester
- CAS:
- 1912-30-7
- MF:
- C4H10O3S
- Structure:
- Chemical Name:
- DONEPEZIL HYDROCHLORIDE
- CAS:
- 110119-84-1
- MF:
- C24H30ClNO3
- Structure:
- Chemical Name:
- 2-aminobutanenitrile
- CAS:
- 40651-89-6
- MF:
- C4H8N2
- Structure:
- Chemical Name:
- 4-Nitrofluorobenzol
- CAS:
- 352-15-8
- MF:
- C6H4FNO
- Structure:
- Chemical Name:
- propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]-
- CAS:
- 144702-27-2
- MF:
- C33H29N5
- Structure:
- Chemical Name:
- 4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid
- CAS:
- 72570-70-8
- MF:
- C13H19NO4
- Structure:
- Chemical Name:
- Fluvoxamino Acid
- CAS:
- 192876-02-1
- MF:
- C14H19F3N2O2
- Structure:
- Chemical Name:
- Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity)
- CAS:
- 93936-64-2
- MF:
- C23H23FNNaO4
- Structure:
- Chemical Name:
- 1-(4-hydroxy-2-methoxyphenyl)ethanone
- CAS:
- 493-33-4
- MF:
- C9H10O3
- Structure:
- Chemical Name:
- 3,5-androstadien-17-one
- CAS:
- 1912-63-6
- MF:
- C19H26O
- Structure:
- Chemical Name:
- (2S,5R)-3α-Chloromethyl-3-methyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2β-carboxylic acid benzhydryl ester
- CAS:
- 85573-73-5
- MF:
- C21H20ClNO3S
- Structure:
- Chemical Name:
- 2-Propylidenepropanedinitrile
- CAS:
- 52833-34-8
- MF:
- C6H6N2
- Structure:
- Chemical Name:
- 4,4'-Dihydroxyazoxybenzene
- CAS:
- 15596-57-3
- MF:
- C12H10N2O3
- Structure:
- Chemical Name:
- 5-[[(2-Aminoethyl)thio]methyl]-N,N-dimethyl-2-furfurylamine
- CAS:
- 66356-53-4
- MF:
- C10H18N2OS
- Structure:
- Chemical Name:
- 2-[2-(2-METHOXY-PHENOXY)-ETHYL]-ISOINDOLE-1,3-DIONE
- CAS:
- 26646-63-9
- MF:
- C17H15NO4
- Structure:
- Chemical Name:
- (3AS,7AS)-HEXAHYDRO-1H-ISOINDOLE-1,3(2H)-DIONE
- CAS:
- 117307-09-2
- MF:
- C8H11NO2
- Structure:
- Chemical Name:
- Amifostine Thiol Dihydrochloride
- CAS:
- 14653-77-1
- MF:
- C5H14N2S
- Structure:
- Chemical Name:
- Butyl Itraconazole
- CAS:
- 89848-51-1
- MF:
- C35H38Cl2N8O4
- Structure:
- Chemical Name:
- Betamethasone 9,11-Epoxide Propionate
- CAS:
- 205105-83-5
- MF:
- C25H32O6
- Structure:
- Chemical Name:
- 8-Methoxyquinolin-2(1H)-one
- CAS:
- 22614-69-3
- MF:
- C10H9NO2
- Structure:
- Chemical Name:
- 7-Bromo Epinastine
- CAS:
- 1217052-16-8
- MF:
- C16H14BrN3
- Structure:
- Chemical Name:
- 1,3-Bis[4-(2-methoxyethyl)phenoxy]-
- CAS:
- 230975-30-1
- MF:
- C21H28O5
- Structure:
- Chemical Name:
- 5-Deshydroxymethyl-5-chloro Losartan (Losartan Impurity K)
- CAS:
- 1159977-26-0
- MF:
- C21H20Cl2N6
- Structure:
- Chemical Name:
- Desfluoro Fluvoxamine
- CAS:
- 1217214-94-2
- MF:
- C15H22F2N2O2
- Structure:
- Chemical Name:
- Nilotinib N-Oxide
- CAS:
- 1246817-85-5
- MF:
- C28H22F3N7O2
- Structure:
- Chemical Name:
- Bis[(2-guanidino-4-thiazolyl)methyl]disulfide
- CAS:
- 129083-44-9
- MF:
- C10H14N8S4
- Structure:
- Chemical Name:
- N-[(1R,3r,5S)-9-azabicyclo[3.3.1]non-3-yl]-1-Methyl-1H-indazole-3-carboxaMide hydrochloride
- CAS:
- 141136-01-8
- MF:
- C17H23ClN4O
- Structure:
- Chemical Name:
- 3-AMino-4-(2-chlorophenyl)-6-nitro-2(1H)-quinolinone
- CAS:
- 55198-89-5
- MF:
- C15H10ClN3O3
- Structure:
- Chemical Name:
- 3-Dehydroxy-3-oxo-4,5-dihydro OxazepaM
- CAS:
- 19554-95-1
- MF:
- C15H11ClN2O2
- Structure:
- Chemical Name:
- 8-DeMethyl Ivabradine
- CAS:
- 304464-97-9
- MF:
- C26H34N2O5
- Structure:
- Chemical Name:
- CitalopraM DiMethylaMinobutanone
- CAS:
- 1329745-98-3
- MF:
- C25H33FN2O2
- Structure:
- Chemical Name:
- DesMethyl Erlotinib Carboxylate Acid
- CAS:
- 882172-60-3
- MF:
- C21H19N3O5
- Structure:
- Chemical Name:
- [[4-[(3-Methylphenyl)aMino]-3-pyridinyl]sulfonyl]carbaMic Acid Ethyl Ester
- CAS:
- 72810-57-2
- MF:
- C15H17N3O4S
- Structure:
- Chemical Name:
- 12-Hydroxy Irinotecan
- CAS:
- 185336-12-3
- MF:
- C33H38N4O7
- Structure:
- Chemical Name:
- Losartan IsoMer IMpurity, PotassiuM Salt
- CAS:
- 860644-28-6
- MF:
- C22H22ClKN6O
- Structure:
- Chemical Name:
- PidotiMod Diketopiperazine-6-propanoic Acid
- CAS:
- 161771-75-1
- MF:
- C9H12N2O4S
- Structure:
- Chemical Name:
- RofluMilast N-Oxide
- CAS:
- 292135-78-5
- MF:
- C17H14Cl2F2N2O4
- Chemical Name:
- AzithroMycin IMpurity J
- Structure:
- Chemical Name:
- EsMolol Acid SodiuM Salt
- CAS:
- 83356-60-9
- MF:
- C15H22NNaO4
- Structure:
- Chemical Name:
- Thyroxine Ethyl Ester
- CAS:
- 76353-71-4
- MF:
- C17H15I4NO4
- Structure:
- Chemical Name:
- (4-Chlorophenyl)[4-(1-Methylethoxy)phenyl]Methanone (Fenofibrate IMpurity)
- CAS:
- 154356-96-4
- MF:
- C16H15ClO2
- Structure:
- Chemical Name:
- 5-Acetyl Rhein
- CAS:
- 875535-35-6
- MF:
- C17H10O7
- Structure:
- Chemical Name:
- 3-phenylpyrazin-2-ol
- CAS:
- 73200-73-4
- MF:
- C10H8N2O
- Structure:
- Chemical Name:
- BIRG 616 BS
- CAS:
- 287980-84-1
- MF:
- C12H10N4O
- Structure:
- Chemical Name:
- 7'-Methyl-2'-propyl-1H,3'H-2,5'-bibenzo[d]iMidazole
- CAS:
- 884330-09-0
- MF:
- C18H18N4
- Structure:
- Chemical Name:
- 5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethanol
- CAS:
- 112935-93-0
- MF:
- C14H20N2O5
- Structure:
- Chemical Name:
- Deoxy Fesoterodine
- CAS:
- 895137-81-2
- MF:
- C26H37NO2
- Structure:
- Chemical Name:
- Cyantraniliprole
- CAS:
- 736994-63-1
- MF:
- C19H14BrClN6O2
- Structure:
- Chemical Name:
- Bisacodyl Related Compound C (20 mg) (4-[(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl acetate)
- CAS:
- 72901-16-7
- MF:
- C20H17NO3
- Structure:
- Chemical Name:
- (6R,7R)-7-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 5-oxide
- CAS:
- 934986-48-8
- MF:
- C14H13N5O6S2
- Structure:
- Chemical Name:
- (2S)-1-[(2S)-2-Methyl-3-Methylsulfinylpropanoyl]pyrrolidine-2-carboxylic acid
- CAS:
- 78636-31-4
- MF:
- C14H22N2O6S2
- Structure:
- Chemical Name:
- Aripiprazole Related CoMpound B
- CAS:
- 1424858-02-5
- MF:
- C26H32N2O5
- Chemical Name:
- penilloic acids of piperacillin
- Structure:
- Chemical Name:
- 2-PyrazinecarboxaMide, 6-nitro-3,4-dihydro-3-oxo-
- CAS:
- 259793-97-0
- MF:
- C5H4N4O4
- Chemical Name:
- IMp. C (EP)
- Structure:
- Chemical Name:
- Methyl 3-aMino-2-((2'-carbaMoylbiphenyl-4-yl)MethylaMino)benzoate
- CAS:
- 147404-75-9
- MF:
- C22H21N3O3
- Structure:
- Chemical Name:
- 3-Methyl cefdinir
- CAS:
- 71091-93-5
- MF:
- C13H13N5O5S2
- Structure:
- Chemical Name:
- 2-[[[4-(2,2,2-Trifluoroethoxy)-3-Methyl-1-oxopyridin-2-yl]Methyl]sulfanyl]-1H-benziMidazole
- CAS:
- 163119-30-0
- MF:
- C16H14F3N3O2S
- Structure:
- Chemical Name:
- (11β,16β)-9-BroMo-11-hydroxy-16-Methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione
- CAS:
- 52092-14-5
- MF:
- C28H37BrO7
- Structure:
- Chemical Name:
- ClotriMazole IMpurity A
- CAS:
- 23593-71-7
- MF:
- C22H17ClN2
- Structure:
- Chemical Name:
- 9-Nitrominocycline
- CAS:
- 149934-16-7
- MF:
- C23H26N4O9
- Structure:
- Chemical Name:
- N-(3,5-DiMethyladaMantan-1-yl)forMaMide
- CAS:
- 351329-88-9
- MF:
- C13H21NO
- Structure:
- Chemical Name:
- N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide
- CAS:
- 51765-72-1
- MF:
- C14H14N2O7S2
- Structure:
- Chemical Name:
- Olanzapine ThioacetoxyMethylidene IMpurity Discontinued
- CAS:
- 1320360-87-9
- MF:
- C17H20N4O2S
- Structure:
- Chemical Name:
- 1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]-
- CAS:
- 1385018-57-4
- MF:
- C26H27NO2
- Structure:
- Chemical Name:
- 24R-Calcipotriol
- CAS:
- 112827-99-3
- MF:
- C27H40O3
- Chemical Name:
- Methotrexate IMpurity C
- Structure:
- Chemical Name:
- Paroxetine EP IMpurity G
- CAS:
- 69675-10-1
- MF:
- C12H14FN
- Chemical Name:
- Itraconazole impurity C
- Structure:
- Chemical Name:
- 1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- CAS:
- 143158-55-8
- MF:
- C15H13F2NO4
- Structure:
- Chemical Name:
- (1S,3S,4R)-Entecavir
- CAS:
- 1367369-79-6
- MF:
- C12H15N5O3
- Structure:
- Chemical Name:
- Platycodin D2
- CAS:
- 66663-90-9
- MF:
- C63H102O33
- Structure:
- Chemical Name:
- Prasugrel Impurity III
- CAS:
- 1391194-50-5
- MF:
- C20H20FNO3S
- Structure:
- Chemical Name:
- 2-(4-(6-((5-((2-chloro-6-Methylphenyl)carbaMoyl)thiazol-2-yl)aMino)-2-MethylpyriMidin-4-yl)piperazin-1-yl)ethyl acetate
- CAS:
- 1245157-85-0
- MF:
- C24H28ClN7O3S
- Structure:
- Chemical Name:
- Ebastine IMpurity F
- CAS:
- 1429071-63-5
- MF:
- C32H39NO3
- Structure:
- Chemical Name:
- N-((S)-1-(((R)-1-Hydroxy-3-Methylbutyl)aMino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide
- CAS:
- 289472-78-2
- MF:
- C19H24N4O3
- Structure:
- Chemical Name:
- AMoxicillin iMpurity J
- CAS:
- 2088960-43-2
- MF:
- C32H38N6O10S2
- Structure:
- Chemical Name:
- Azilsartan iMpurity O
- CAS:
- 2171316-29-1
- MF:
- C23H19N3O4
- Chemical Name:
- cefoxitin iMpurity C
- Structure:
- Chemical Name:
- 3-((3R,4R)-3-((2-chloro-7H-pyrrolo[2,3-d]pyriMidin-4-yl)(Methyl)aMino)-4-Methylpiperidin-1-yl)-3-oxopropanenitrile
- CAS:
- 1616761-00-2
- MF:
- C16H19ClN6O
- Structure:
- Chemical Name:
- Aprepitant iMpurity
- CAS:
- 96730-04-0
- MF:
- C13H22NO4P
- Structure:
- Chemical Name:
- Doxofylline iMpurity
- CAS:
- 254760-82-2
- MF:
- C11H16N4O4
- Chemical Name:
- forMoterol iMpurity
- Structure:
- Chemical Name:
- LevetiracetaM IMpurity 4
- CAS:
- 1342229-32-6
- MF:
- C10H19NO4
- Structure:
- Chemical Name:
- cinacalcet iMpurity 4
- CAS:
- 955373-56-5
- MF:
- C22H20F3N
- Chemical Name:
- Acyclovir IMpurity J