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:
- Amlodipine Impurity 17
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Edoxaban Impurity 12 (1R,2R,4S)
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 26
- CAS:
- 1838133-00-8
- MF:
- C23H21Cl2N3O5S2
- Structure:
- Chemical Name:
- Erlotinib
- CAS:
- 938185-06-9
- MF:
- C16H11N3O2
- Structure:
- Chemical Name:
- methyl (41R,12S,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:
- 18374-18-0
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- Brexpiprazole sulfoxide impurity
- CAS:
- 1191900-51-2
- MF:
- C25H27N3O3S
- Chemical Name:
- Cabozantinib Impurity H
- Structure:
- Chemical Name:
- Clopidogrel Impurity 11
- MF:
- C15H14ClNO2S
- Structure:
- Chemical Name:
- Medetomidine Impurity 3
- CAS:
- 104245-83-2
- MF:
- C10H13Cl
- Chemical Name:
- Tofacitinib Impurity 35
- Structure:
- Chemical Name:
- ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate
- CAS:
- 1884279-18-8
- MF:
- C18H17NO4S
- Structure:
- Chemical Name:
- N-methyl-1-(5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methanamine fumarate
- CAS:
- 928325-82-0
- MF:
- C21H21N3O6S
- Structure:
- Chemical Name:
- Phenol, 2,4-dibromo-3-methyl-
- CAS:
- 13321-75-0
- MF:
- C7H6Br2O
- Structure:
- Chemical Name:
- N-((4-FLUOROPHENYL)METHYL)ETHANAMIDE
- CAS:
- 86010-68-6
- MF:
- C9H10FNO
- Structure:
- Chemical Name:
- Benzenediazonium, 4-(ethoxycarbonyl)-, chloride
- CAS:
- 2028-79-7
- MF:
- C9H9ClN2O2
- Structure:
- Chemical Name:
- 2,4-Pteridinediamine,6-(methoxymethyl)-
- CAS:
- 40110-13-2
- MF:
- C8H10N6O
- Structure:
- Chemical Name:
- Fingolimod EP Impurity D
- CAS:
- 780729-32-0
- MF:
- C21H37NO2
- Structure:
- Chemical Name:
- Pentanedioic acid, 2,4-diacetyl-3-(3-nitrophenyl)-, dimethyl ester
- CAS:
- 89080-61-5
- MF:
- C17H19NO8
- Structure:
- Chemical Name:
- Ethanone, 1-[3,5-bis(phenylmethoxy)phenyl]-2-[(1,1-dimethylethyl)(phenylmethyl)amino]-, sulfate (1:1)
- CAS:
- 52144-93-1
- MF:
- C33H37NO7S
- Structure:
- Chemical Name:
- 2-Thiazoleacetic acid,4-carboxy-2,5-dihydro-5-(4-hydroxybutylidene)-a-[(1R)-1-hydroxyethyl]-, disodium salt, (aS,2R,5Z)- (9CI)
- CAS:
- 130609-10-8
- MF:
- C12H18NNaO6S
- Structure:
- Chemical Name:
- 4,4'-Iminodiphenol hydrochloride
- CAS:
- 1965310-24-0
- MF:
- C12H12ClNO2
- Chemical Name:
- Cefradine Impurity D
- Structure:
- Chemical Name:
- WIXOVOWSUCEDGS-UHFFFAOYSA-N
- CAS:
- 1346603-05-1
- MF:
- C15H20O5
- Structure:
- Chemical Name:
- YXSRVOWUJUXDLJ-UHFFFAOYSA-N
- CAS:
- 1618107-97-3
- MF:
- C18H18FNO2S
- Structure:
- Chemical Name:
- S-2-Benzothiazolyl-2-amino-±-(methoxyimino)-4-thiazolethiolacetate
- CAS:
- 1684396-27-7
- MF:
- C13H10N4O2S3
- Structure:
- Chemical Name:
- 4-[[(1,1-DIMETHYLETHOXY)CARBONYL]AMINO]-2-CYCLOPENTENE-1-CARBOXYLIC ACID METHYL ESTER
- CAS:
- 168683-02-1
- MF:
- C12H19NO4
- Structure:
- Chemical Name:
- KNKJEUNXMFFFDU-LZHIOSKDSA-N
- CAS:
- 138804-88-3
- MF:
- C25H34O6
- Structure:
- Chemical Name:
- MONO-DESACETYL FAMCICLOVIR
- CAS:
- 104227-88-5
- MF:
- C12H17N5O3
- Structure:
- Chemical Name:
- (E)-5-(2-CARBOXYVINYL)-2'-DEOXYURIDINE
- CAS:
- 74131-06-9
- MF:
- C12H14N2O7
- Structure:
- Chemical Name:
- HHUBRUYPYDODRB-UHFFFAOYSA-N
- CAS:
- 106860-70-2
- MF:
- C8H5NO5
- Structure:
- Chemical Name:
- 1-(2,3-EPOXYPROPYL)-2-METHYL-5-NITROIMIDAZOLE
- CAS:
- 16773-52-7
- MF:
- C7H9N3O3
- Chemical Name:
- Bendamustine Related Impurity 12
- Chemical Name:
- Bendamustine Related Impurity 3
- Structure:
- Chemical Name:
- Edoxaban Impurity 26 (1R,2S,4R)
- CAS:
- 1255529-33-9
- MF:
- C21H30ClN5O5
- Structure:
- Chemical Name:
- Ezetimibe Impurity 36
- CAS:
- 1809031-15-9
- MF:
- C39H46F2N2O5Si2
- Structure:
- Chemical Name:
- Linagliptin Impurity 29
- CAS:
- 2074688-82-5
- MF:
- C58H58N16O6
- Structure:
- Chemical Name:
- Methylprednisolone Acetate EP Impurity H
- CAS:
- 1968-76-9
- MF:
- C24H32O4
- Chemical Name:
- Rivaroxaban Impurity 44
- Chemical Name:
- Sitafloxacin Impurity 3
- Chemical Name:
- Tenofovir Impurity 39
- Chemical Name:
- Ticagrelor Related Compound 82
- Chemical Name:
- Vonoprazan Impurity 20
- Structure:
- Chemical Name:
- N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(4-methoxyphenoxy)propyl]-1-piperazineacetamide
- CAS:
- 1393717-45-7
- MF:
- C24H33N3O4
- Structure:
- Chemical Name:
- methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(ethyl)carbamate
- CAS:
- 1361570-27-5
- MF:
- C21H21FN8O2
- Chemical Name:
- Cefathiamidine Impurity G
- Chemical Name:
- Olaparib Impurity P
- Chemical Name:
- Ozagrel Impurity 1
- Chemical Name:
- Pidotimod Impurity P
- Chemical Name:
- Pitavastatin Impurity 11
- Chemical Name:
- Pramipexole Impurity 18
- Chemical Name:
- Tenofovir disoproxil Impurity 18
- Chemical Name:
- Tenofovir Impurity 50
- Structure:
- Chemical Name:
- Darunavir
- CAS:
- 1526916-57-3
- MF:
- C22H31N3O5S
- Structure:
- Chemical Name:
- (S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran
- MF:
- C17H16Br2O2
- Structure:
- Chemical Name:
- 5-Decyano 5-(Ethyl Formate) Milrinone
- CAS:
- 80442-07-5
- MF:
- C14H14N2O3
- Structure:
- Chemical Name:
- 25-DESACETYL RIFAMPICIN
- CAS:
- 16783-99-6
- MF:
- C41H56N4O11
- Structure:
- Chemical Name:
- ETHYL 2-CYCLOHEXYL-2-HYDROXY-PHENYLACETATE
- CAS:
- 31197-69-0
- MF:
- C16H22O3
- Structure:
- Chemical Name:
- 1-(4-methoxyphenyl)-2-methylpropan-2-ol
- CAS:
- 35144-39-9
- MF:
- C11H16O2
- Structure:
- Chemical Name:
- Apixaban Impurity 33
- CAS:
- 1686149-78-9
- MF:
- C21H27N3O3
- Structure:
- Chemical Name:
- 1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane
- CAS:
- 414858-02-9
- MF:
- C46H84N12
- Structure:
- Chemical Name:
- butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate
- CAS:
- 2227199-31-5
- MF:
- C20H29N5O3
- Structure:
- Chemical Name:
- ethyl 2-((E)-5-((E)-2-methyl-3-phenylallylidene)-4-oxo-2-thioxothiazolidin-3-yl)acetate
- CAS:
- 682775-71-9
- MF:
- C17H17NO3S2
- Structure:
- Chemical Name:
- Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
- CAS:
- 24683-26-9
- MF:
- C12H13NO5S
- Structure:
- Chemical Name:
- Sugammadex
- CAS:
- 1378831-29-8
- MF:
- C6H10O3S2
- Structure:
- Chemical Name:
- Petunidin 3-O-glucoside
- CAS:
- 71991-88-3
- MF:
- C22H23O12+
- Structure:
- Chemical Name:
- 1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride
- CAS:
- 70918-74-0
- MF:
- C13H17ClN2O3
- Structure:
- Chemical Name:
- [4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate
- CAS:
- 41859-56-7
- MF:
- C22H17Cl2NO3
- Structure:
- Chemical Name:
- N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE
- CAS:
- 67669-19-6
- MF:
- C8H7Cl2NO2
- Structure:
- Chemical Name:
- 2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE
- CAS:
- 128430-66-0
- MF:
- C9H9ClF3NO
- Chemical Name:
- Alogliptin Impurity 7
- Structure:
- Chemical Name:
- diethyl 2-(2-bromoethyl)-malonate
- CAS:
- 18721-64-7
- MF:
- C9H15BrO4
- Structure:
- Chemical Name:
- methyl 2,5-dihydroxybenzenesulfonate
- MF:
- C7H8O5S
- Chemical Name:
- Pinocembroside,Pinocembrin41-O-beta-D-glucoside
- Structure:
- Chemical Name:
- 4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate
- CAS:
- 123441-05-4
- MF:
- C14H22N2O2
- Structure:
- Chemical Name:
- Dapagliflozin mono acetyl impurity
- CAS:
- 1632287-34-3
- MF:
- C23H27ClO7
- Chemical Name:
- Piperacillin Impurity 3
- Structure:
- Chemical Name:
- Varenicline Impurity 5
- CAS:
- 950781-87-0
- MF:
- C11H13N3O2
- Structure:
- Chemical Name:
- 4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL
- CAS:
- 30165-97-0
- MF:
- C6H9N3O2S
- Structure:
- Chemical Name:
- Amlodipine Impurity 29
- CAS:
- 93848-82-9
- MF:
- C22H27ClN2O6
- Structure:
- Chemical Name:
- Amlodipine Impurity 34
- MF:
- C26H31ClN2O8S
- Structure:
- Chemical Name:
- 1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine
- CAS:
- 53877-76-2
- MF:
- C17H24N2
- Structure:
- Chemical Name:
- propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
- CAS:
- 1112262-71-1
- MF:
- C39H45FN2O5
- Structure:
- Chemical Name:
- Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)-
- CAS:
- 58404-37-8
- MF:
- C23H28O7
- Structure:
- Chemical Name:
- TYRPHOSTIN AG 1290
- CAS:
- 160391-70-8
- MF:
- C10H6N2O6
- Structure:
- Chemical Name:
- Verapamil Impurity N
- CAS:
- 2086274-75-9
- MF:
- C33H47N3O4
- Structure:
- Chemical Name:
- Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)-
- CAS:
- 478-83-1
- MF:
- C16H15BrN2O2
- Chemical Name:
- Adefovir Impurity 6
- Chemical Name:
- Apremilast Impurity QY
- Chemical Name:
- Dextrorotation lansoprazole Impurity J
- Chemical Name:
- Dextrorotation lansoprazole-N-oxide
- Chemical Name:
- lansoprazole Impurity 23
- Chemical Name:
- lansoprazole Impurity 29
- Structure:
- Chemical Name:
- Loratadine Impurity L
- MF:
- C22H23ClN2O2
- Chemical Name:
- meta-dyhydroxy Sugammadex sodium Impurity 1
- Structure:
- Chemical Name:
- Olanzapine impurity R
- MF:
- C17H20N4S
- Chemical Name:
- Palbociclib Impurity 33
- Chemical Name:
- Pramipexole Related Impurity 1
- Chemical Name:
- Ropivacaine Impurity 37
- Chemical Name:
- Ropivacaine Impurity 42
- Chemical Name:
- Sugammadex sodium Org197339-1 Impurity