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:
- Pemetrexed Disodium Impurity 21-30
- Chemical Name:
- Bimatoprost Impurity 2
- Structure:
- Chemical Name:
- Guanosine
- CAS:
- 30747-23-0
- MF:
- C18H21N5O9
- Chemical Name:
- Minoxidil Impurity G
- Chemical Name:
- Brivaracet amoxidation Impurity 2
- Chemical Name:
- Sugammadex Impurity U
- Chemical Name:
- 3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)-[1,1'-biphenyl]-2,2'-dicarbonitrile
- Chemical Name:
- Cefmetazole Sodium Impurity B
- Chemical Name:
- (3R,5S,E)-tert-butyl 7-(4-(3-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate
- Structure:
- Chemical Name:
- 1-Piperazinebutanol, 4-(1,2-benzisothiazol-3-yl)-
- CAS:
- 159729-16-5
- MF:
- C15H21N3OS
- Structure:
- Chemical Name:
- 1,4-Piperazinedibutanol
- CAS:
- 92036-96-9
- MF:
- C12H26N2O2
- Structure:
- Chemical Name:
- 1H-Benz[de]isoquinolin-1-one, 2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-6-hydroxy-, (3aS)-
- CAS:
- 2446343-19-5
- MF:
- C19H24N2O2
- Chemical Name:
- Peramivir Impurity 70
- Structure:
- Chemical Name:
- PANTOPRAZOLE SULFONE N-OXIDE
- CAS:
- 953787-55-8
- MF:
- C16H15F2N3O6S
- Chemical Name:
- (R)-5-(aminomethyl)-2-((R)-carboxy((Z)-2-(furan-2-yl)-2-(methoxyimino)acetamido)methyl)-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid
- Chemical Name:
- Isavuconazole Impurity 44
- Structure:
- Chemical Name:
- Cobinic acid-abdeg-pentamide, Co-(cyano-κC)-, dihydrogen phosphate (ester), inner salt, 3'-ester with (5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole-κN3) (9CI)
- CAS:
- 38437-93-3
- MF:
- C63H87CoN13O15P
- Chemical Name:
- Avatrombopag Impurity 75
- Chemical Name:
- Atorvastatin Impurity N(Calcium salt
- Chemical Name:
- Rosuvastatin Impurity 164
- Chemical Name:
- Rosuvastatin Impurity 123
- Chemical Name:
- Relugolix Impurity 20
- Chemical Name:
- Amoxicillin EP Impurity Q
- Chemical Name:
- 7-PACE Impurity 2
- Structure:
- Chemical Name:
- 5-(1-Methyl-4-Piperidyl)5H-Dibenzo
- CAS:
- 3967-32-6
- MF:
- C21H23NO
- Chemical Name:
- Ertapenem Impurity I(USP)
- Structure:
- Chemical Name:
- Acetonitrile, (3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)-, (Z)- (9CI)
- CAS:
- 178676-66-9
- MF:
- C13H13NO
- Structure:
- Chemical Name:
- Aflatoxin
- CAS:
- 1402-68-2
- MF:
- C17H14O6.C17H14O7.C17H12O6.C17H12O7
- Chemical Name:
- Penicillin EP Impurity A
- Chemical Name:
- Voriconzolegenotoxicimpurity
- Structure:
- Chemical Name:
- 1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl-
- CAS:
- 956344-27-7
- MF:
- C14H19N3O3
- Chemical Name:
- Iohexol ImpuritiesD
- Chemical Name:
- ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate
- Chemical Name:
- 2-Demethoxy-2-chloro Urapidil HCl
- Chemical Name:
- Isavuconazole Impurity 43
- Chemical Name:
- Elagolix Impurity 41
- Chemical Name:
- Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate
- Chemical Name:
- 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
- Chemical Name:
- Bumetanide Impurity 18
- Structure:
- Chemical Name:
- delta(3)-cefotiam
- CAS:
- 142182-63-6
- MF:
- C18H23N9O4S3
- Structure:
- Chemical Name:
- anemonin
- CAS:
- 508-44-1
- MF:
- C10H8O4
- Structure:
- Chemical Name:
- alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol
- CAS:
- 62580-79-4
- MF:
- C7H10ClN3O4
- Structure:
- Chemical Name:
- 7-(deoxyadenosin-N(6)-yl)aristolactam I
- CAS:
- 127191-86-0
- MF:
- C27H22N6O7
- Structure:
- Chemical Name:
- 4-CHLORO-3,5-DIMETHYL 2-CHLORMETHYL PYRIDINE.HCL
- CAS:
- 142885-96-9
- MF:
- C8H9Cl2N
- Structure:
- Chemical Name:
- 9-DIHYDROESTRADIOL
- CAS:
- 791-69-5
- MF:
- C18H22O2
- Structure:
- Chemical Name:
- (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity)
- CAS:
- 130676-66-3
- MF:
- C29H55NO6
- Structure:
- Chemical Name:
- (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity)
- CAS:
- 130676-66-3
- MF:
- C29H55NO6
- Structure:
- Chemical Name:
- Pramipexole EP Impurity E
- CAS:
- 106006-84-2
- MF:
- C10H15N3OS
- Structure:
- Chemical Name:
- 3-Morpholinone, 4-phenyl-
- CAS:
- 29518-11-4
- MF:
- C10H11NO2
- Structure:
- Chemical Name:
- H 128/80
- CAS:
- 29122-74-5
- MF:
- C13H19NO3
- Structure:
- Chemical Name:
- 4’-Hydroxy Atomoxetine -D-Glucuronide
- CAS:
- 540729-08-6
- MF:
- C23H29NO8
- Structure:
- Chemical Name:
- Decarboxy Ciprofloxacin
- CAS:
- 105394-83-0
- MF:
- C16H18FN3O
- Structure:
- Chemical Name:
- 4-BROMO-1-(TOLUENE-4-SULFONYL)-1,2,3,4-TETRAHYDROBENZO[B]AZEPIN-5-ONE
- CAS:
- 29489-04-1
- MF:
- C17H16BrNO3S
- Chemical Name:
- Lincomycin sulfoxide Impurity 4
- Chemical Name:
- Sulpiride Impurity 3
- Chemical Name:
- Doxofylline iMpurity F
- Chemical Name:
- He pulls non-EP impurities D
- Structure:
- Chemical Name:
- R-(-)-O-DESMETHYLVENLAFAXINE
- CAS:
- 142761-11-3
- MF:
- C16H25NO2
- Structure:
- Chemical Name:
- MILRINONE RELATED COMPOUND A (50 MG) (1,6-DIHYDRO-2-METHYL-6-OXO(3,4'-BIPYRIDINE)-5-CAR-BOXAMIDE)
- CAS:
- 80047-24-1
- MF:
- C12H11N3O2
- Structure:
- Chemical Name:
- 3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers)
- CAS:
- 30078-48-9
- MF:
- C19H20N2O3
- Structure:
- Chemical Name:
- Anastrozole EP Impurity I
- CAS:
- 120511-91-3
- MF:
- C15H17ClN2
- Structure:
- Chemical Name:
- (2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester
- CAS:
- 389128-28-3
- MF:
- C18H26N2O5S
- Chemical Name:
- Rocuronium Bromide Impurity 19 、21、22
- Chemical Name:
- Flucloxacillin impurity D
- Chemical Name:
- Ritonavir EP Impurity STU
- Chemical Name:
- Letermovir Impurity 1
- Chemical Name:
- Roxadustat Impurity 16
- Chemical Name:
- Perospirone Impurity 19
- Chemical Name:
- Dolutegravir Impurity 14(Sodium Salt)
- Chemical Name:
- Fondaparinux sodium impurity 5
- Chemical Name:
- Fondaparinux sodium impurity 20
- Chemical Name:
- Piperacillin Impurity R
- Chemical Name:
- Lasmiditan Impurity 6
- Chemical Name:
- 1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride
- Chemical Name:
- Lasmiditan Impurity 8
- Structure:
- Chemical Name:
- 1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate
- CAS:
- 2760465-02-7
- MF:
- C17H22N4O2S
- Structure:
- Chemical Name:
- Ethacridine Impurity 10
- CAS:
- 20304-71-6
- MF:
- C21H16N2O4
- Structure:
- Chemical Name:
- (S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide
- CAS:
- 135729-78-1
- MF:
- C18H24N2O
- Chemical Name:
- 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
- Chemical Name:
- Olodaterol Impurity 31
- Structure:
- Chemical Name:
- (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
- CAS:
- 192726-05-9
- MF:
- C27H38N4O3
- Structure:
- Chemical Name:
- 2-Hydrazinoadenosine
- CAS:
- 15763-11-8
- MF:
- C10H15N7O4
- Structure:
- Chemical Name:
- N-Desmethyl Clarithromycin
- CAS:
- 101666-68-6
- MF:
- C37H67NO13
- Chemical Name:
- Oseltamivir Impurity 126
- Chemical Name:
- Oseltamivir Impurity 126
- Structure:
- Chemical Name:
- 2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1)
- CAS:
- 936490-85-6
- MF:
- C20H25ClN2O5
- Structure:
- Chemical Name:
- Desacetylvinblastine hydrazide
- CAS:
- 55383-37-4
- MF:
- C43H56N6O7
- Structure:
- Chemical Name:
- 4-hydroxypyrrolidin-2-one
- CAS:
- 96820-00-7
- MF:
- C4H7NO2
- Structure:
- Chemical Name:
- glycopyrronium bromide
- CAS:
- 475468-09-8
- MF:
- C19H28NO3.Br
- Structure:
- Chemical Name:
- protosappanin A
- CAS:
- 102036-28-2
- MF:
- C15H12O5
- Structure:
- Chemical Name:
- 4'-hydroxyflurbiprofen
- CAS:
- 52807-12-2
- MF:
- C15H13FO3
- Structure:
- Chemical Name:
- D-biotin-d-sulfoxide
- CAS:
- 10406-89-0
- MF:
- C10H16N2O4S
- Structure:
- Chemical Name:
- 3,4-dihydroxyphenylpyruvic acid
- CAS:
- 4228-66-4
- MF:
- C9H8O5
- Chemical Name:
- Imimidistine impurity E
- Structure:
- Chemical Name:
- 4-hydroxypenicillin V
- CAS:
- 20880-67-5
- MF:
- C16H18N2O6S
- Structure:
- Chemical Name:
- BENAZEPRILAT
- CAS:
- 86541-78-8
- MF:
- C22H24N2O5
- Structure:
- Chemical Name:
- 9-Methylene-9H-fluorene
- CAS:
- 4425-82-5
- MF:
- C14H10
- Structure:
- Chemical Name:
- 2-PIPERIDIN-4-YL-1H-BENZOIMIDAZOLE
- CAS:
- 38385-95-4
- MF:
- C12H15N3