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:
- AMIKACIN IMPURITY A
- Chemical Name:
- ONDANSETRON IMPURITY D
- Chemical Name:
- PERINDOPRIL IMPURITY A
- Structure:
- Chemical Name:
- (E)-Ceftiofur
- CAS:
- 120882-20-4
- MF:
- C19H17N5O7S3
- Structure:
- Chemical Name:
- Brivaracetam Impurity 25
- CAS:
- 10547-88-3
- MF:
- C7H12O2
- Chemical Name:
- Peramivir Impurity 19
- Structure:
- Chemical Name:
- Diquafosol Impurity 13
- CAS:
- 211448-81-6
- MF:
- C18H28N4O29P6
- Structure:
- Chemical Name:
- Montelukast Sodium EP Impurity G
- CAS:
- 1428448-96-7
- MF:
- C35H37ClNNaO3S
- Structure:
- Chemical Name:
- Amifostine related impurities 2
- CAS:
- 17002-55-0
- MF:
- C8H21N3O
- Structure:
- Chemical Name:
- Oxacillin Impurity F
- CAS:
- 5053-35-0
- MF:
- C19H19N3O4S2
- Structure:
- Chemical Name:
- Peramivir Impurity 30
- CAS:
- 2758048-79-0
- MF:
- C20H36N2O6
- Structure:
- Chemical Name:
- 2-Benzylidene isobutyryl acetanilide
- CAS:
- 125971-57-5
- MF:
- C19H19NO2
- Structure:
- Chemical Name:
- ISOPROPYLAMINE HYDROCHLORIDE
- CAS:
- 15572-56-2
- MF:
- C3H10ClN
- Structure:
- Chemical Name:
- 2-METHYLPYRAZINE 1,4-DIOXIDE
- CAS:
- 32046-26-7
- MF:
- C5H6N2O2
- Structure:
- Chemical Name:
- 4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE
- CAS:
- 247583-78-4
- MF:
- C8H14N4O
- Structure:
- Chemical Name:
- Abacavir
- CAS:
- 141271-12-7
- MF:
- C10H14ClN5O
- Chemical Name:
- Bendamustine Related Impurity 2
- Chemical Name:
- Bendamustine Related Impurity 7
- Chemical Name:
- Bortezomib Impurity 25
- Chemical Name:
- Bortezomib Impurity 40
- Structure:
- Chemical Name:
- Edoxaban Impurity 28 (1R,2R,4R)
- CAS:
- 1255529-38-4
- MF:
- C21H30ClN5O5
- Chemical Name:
- Linagliptin Impurity 31
- Structure:
- Chemical Name:
- Olopatadine Impurity 1
- CAS:
- 66801-40-9
- MF:
- C15H10O4
- Chemical Name:
- Paroxetine Impurity 12
- Chemical Name:
- Rivaroxaban Impurity 69 DiHCl
- Structure:
- Chemical Name:
- Sitafloxacin Impurity 5
- CAS:
- 1630983-99-1
- MF:
- C15H12ClF4NO3
- Chemical Name:
- Ticagrelor Related Compound 92
- Structure:
- Chemical Name:
- Valsartan Impurity 10
- CAS:
- 1314799-74-0
- MF:
- C23H29N5O
- Chemical Name:
- Vonoprazan Impurity 23
- Chemical Name:
- Adefovir Impurity 1
- Chemical Name:
- Bendamustine Impurity G
- Chemical Name:
- Blonanserin Impurity K
- Chemical Name:
- Brexpiprazole Impurity F
- Chemical Name:
- Cefazolin USP Impurity D
- Structure:
- Chemical Name:
- Cefuroxime Impurity 9
- CAS:
- 2165460-37-5
- MF:
- C8H10N2O4S
- Chemical Name:
- Everolimus Impurity E
- Chemical Name:
- Peramivir Impurity 3
- Chemical Name:
- Peramivir Impurity 8
- Chemical Name:
- Canagliflozin Impurity 42
- Structure:
- Chemical Name:
- Maleic Acid
- CAS:
- 2170020-79-6
- MF:
- C21H20FN3O6S
- Structure:
- Chemical Name:
- Ozagrel Impurity 21
- CAS:
- 883942-98-1
- MF:
- C23H20N2O4
- Structure:
- Chemical Name:
- Terbutaline Impurity
- CAS:
- 1226543-90-3
- MF:
- C22H20O4
- Structure:
- Chemical Name:
- lidocaine impurity
- CAS:
- 1374010-02-2
- MF:
- C30H36N4O3
- Chemical Name:
- Desloratadine Impurity 7
- Chemical Name:
- Esomeprazole Impurity 28
- Structure:
- Chemical Name:
- ethyl 2-(3-carbamoyl-4-isobutoxyphenyl)-4-methylthiazole-5- carboxylate
- CAS:
- 1346238-15-0
- MF:
- C18H22N2O4S
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1786518-57-7
- MF:
- C13H16N2O3
- Structure:
- Chemical Name:
- Mono Oxidation Sugammadex(Org199425-1)
- CAS:
- 2412953-14-9
- MF:
- C72H113NaO49S8
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 40
- CAS:
- 121577-35-3
- MF:
- C15H16F3NO4
- Structure:
- Chemical Name:
- sodium 2-(((3,4-dimethoxypyridin-2-yl)methyl)thio)-5- hydroxy-4-sulfonatobenzo[d]imidazol-1-ide
- MF:
- C15H13N3Na2O6S2
- Structure:
- Chemical Name:
- Dexmedetomidine-007
- CAS:
- 2240179-63-7
- MF:
- C13H16N2
- Structure:
- Chemical Name:
- 2-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide
- CAS:
- 2304623-37-6
- MF:
- C16H14N2O3S
- Structure:
- Chemical Name:
- 2,6-Dibenzyloxyacetophenone
- CAS:
- 3886-19-9
- MF:
- C22H20O3
- Structure:
- Chemical Name:
- ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate
- CAS:
- 1059630-08-8
- MF:
- C14H17BrN2O2
- Structure:
- Chemical Name:
- diphenhydramine impurity
- MF:
- C17H21NO
- Structure:
- Chemical Name:
- Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride
- CAS:
- 143016-68-6
- MF:
- C8H10Cl3N
- Structure:
- Chemical Name:
- 1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide
- MF:
- C18H23IN4S
- Structure:
- Chemical Name:
- 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid
- CAS:
- 1657014-33-9
- MF:
- C16H16N2O3S
- Structure:
- Chemical Name:
- vildagliptin Impurity O
- CAS:
- 2253194-12-4
- MF:
- C12H18N4O2
- Structure:
- Chemical Name:
- methyl (41R,12S,13aR)-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:
- 38990-17-9
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine
- CAS:
- 1450657-31-4
- MF:
- C12H17NO4S
- Chemical Name:
- Apremilast Impurity D
- Structure:
- Chemical Name:
- Canagliflozin Impurity 17
- CAS:
- 1951467-28-9
- MF:
- C24H23FO6S
- Chemical Name:
- Canagliflozin Impurity 22
- Chemical Name:
- Carfilzomib Impurity 3
- Chemical Name:
- Dolutegravir Impurity 4
- Chemical Name:
- Febuxostat Impurity 20
- Chemical Name:
- Lenvatinib Impurity 1
- Structure:
- Chemical Name:
- methyl (41S,12S,13aR)-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:
- 83508-82-1
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- 4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester
- CAS:
- 1941177-45-2
- MF:
- C29H37N7O3
- Structure:
- Chemical Name:
- Cabozantinib impurity 1
- CAS:
- 748707-58-6
- MF:
- C17H16N2O3
- Structure:
- Chemical Name:
- Amlodipine Impurity 19
- MF:
- C26H31ClN2O8S
- Structure:
- Chemical Name:
- Amlodipine Impurity 9
- CAS:
- 90445-05-9
- MF:
- C26H31ClN2O8S
- Structure:
- Chemical Name:
- Clopidogrel Impurity 7
- CAS:
- 444728-13-6
- MF:
- C15H15ClN2OS
- Structure:
- Chemical Name:
- MFFANMLJBOSKIX-UHFFFAOYSA-N
- CAS:
- 352457-34-2
- MF:
- C9H13N5O2
- Structure:
- Chemical Name:
- 4,4',4''-Methylidenetrisbenzonitrile
- CAS:
- 113402-31-6
- MF:
- C22H13N3
- Structure:
- Chemical Name:
- methyl (2E)-3-(methylamino)but-2-enoate
- CAS:
- 21759-69-3
- MF:
- C6H11NO2
- Structure:
- Chemical Name:
- Entecavir Impurity 5
- CAS:
- 84868-56-4
- MF:
- C21H20O2
- Structure:
- Chemical Name:
- Bisoprolol-d5
- CAS:
- 1189881-87-5
- MF:
- C18H31NO4
- Structure:
- Chemical Name:
- 4-(2-HYDROXY-3-ISOPROPYLAMINO-PROPOXY)-BENZOIC ACID METHYL ESTER
- CAS:
- 33947-97-6
- MF:
- C14H21NO4
- Structure:
- Chemical Name:
- 3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one
- CAS:
- 1346598-52-4
- MF:
- C39H38N10O
- Structure:
- Chemical Name:
- 5-METHYL-3-NITROMETHYL-HEXANOIC ACID
- CAS:
- 181289-21-4
- MF:
- C8H15NO4
- Structure:
- Chemical Name:
- 4(3,4-DICHLOROPHENYL)1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPHTHALENE AMINE RACEMATE
- CAS:
- 140631-53-4
- MF:
- C17H17Cl2N
- Structure:
- Chemical Name:
- (3R,5R)-tert-butyl 7-(2,3-bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate
- CAS:
- 2588261-40-7
- MF:
- C37H42F2N2O5
- Structure:
- Chemical Name:
- (S)-ethyl 2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetate
- CAS:
- 870695-39-9
- MF:
- C8H13NO4
- Structure:
- Chemical Name:
- 4-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-hydroxybenzyl)phthalazin-1(2H)-one
- MF:
- C24H24N4O4
- Structure:
- Chemical Name:
- Diquafosol Impurity 2
- CAS:
- 63785-59-1
- MF:
- C18H25N4O20P3
- Structure:
- Chemical Name:
- N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2,2'-dichloro-N-methyl-7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-amine
- CAS:
- 2459302-87-3
- MF:
- C26H26Cl2N8
- Structure:
- Chemical Name:
- (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(2,2-dichloroacetyl) -2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate
- CAS:
- 1598416-08-0
- MF:
- C22H18Cl2N2O5
- Structure:
- Chemical Name:
- PANTOPRAZOLE N-OXIDE SODIUM SALT
- CAS:
- 1279822-90-0
- MF:
- C16H16F2N3NaO5S
- Structure:
- Chemical Name:
- 3-HYDROXY-THIOBENZAMIDE
- CAS:
- 104317-54-6
- MF:
- C7H7NOS
- Structure:
- Chemical Name:
- Tadalafil impurity 38
- CAS:
- 185750-07-6
- MF:
- C14H15ClN2O3
- Chemical Name:
- Fulvestrant impurity H
- Structure:
- Chemical Name:
- Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt
- CAS:
- 2122800-38-6
- MF:
- C13H19N2NaO3
- Structure:
- Chemical Name:
- 1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate
- CAS:
- 928615-46-7
- MF:
- C17H16FN3O2S
- Structure:
- Chemical Name:
- Pitavastatin Impurity 13
- Chemical Name:
- Pramipexole Impurity R
- Chemical Name:
- Tadalafil Impuirty 21