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:
- Bumetanide Impurity 10
- Chemical Name:
- Cefoxitin EP Impurity E (R-methoxy cefoxitin)
- Structure:
- Chemical Name:
- 4(1H)-Pyrimidinone, 5-amino-6-chloro-2-(propylthio)-
- CAS:
- 2512210-21-6
- MF:
- C7H10ClN3OS
- Structure:
- Chemical Name:
- Carbamic acid, N-[(1S)-1-methyl-2-oxo-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester
- CAS:
- 2151127-61-4
- MF:
- C24H23NO4
- Structure:
- Chemical Name:
- 1-(chloromethyl)-4-(dichloromethyl)benzene
- CAS:
- 7398-44-9
- MF:
- C8H7Cl3
- Structure:
- Chemical Name:
- 4,4'-(propane-1,3-diyl)bismorpholine
- CAS:
- 48152-09-6
- MF:
- C11H22N2O2
- Chemical Name:
- Sitagliptin EP Impurity 4
- Structure:
- Chemical Name:
- 1-[3,5-bis(phenylmethoxy)phenyl]-2-bromoethan-1-one
- CAS:
- 28924-18-7
- MF:
- C22H19BrO3
- Structure:
- Chemical Name:
- Benzenesulfonic acid, 4-[2-(2-chloro-4-hydroxyphenyl)hydrazinyl]-
- CAS:
- 2174956-62-6
- MF:
- C12H11ClN2O4S
- Chemical Name:
- Anastrozole Impurity 13
- Chemical Name:
- Cefotiam impurity 07
- Structure:
- Chemical Name:
- benzo-1,3-dioxol-5-ol acetate
- CAS:
- 326-58-9
- MF:
- C9H8O4
- Structure:
- Chemical Name:
- 2-((4R,6S)-6-(chloromethyl)-2,2-dimethyl- 1,3-dioxan-4-yl)acetic acid
- CAS:
- 775571-58-9
- MF:
- C9H15ClO4
- Structure:
- Chemical Name:
- (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile
- CAS:
- 178676-65-8
- MF:
- C13H13NO
- Structure:
- Chemical Name:
- (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile
- CAS:
- 178676-65-8
- MF:
- C13H13NO
- Structure:
- Chemical Name:
- (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile
- CAS:
- 178676-65-8
- MF:
- C13H13NO
- Structure:
- Chemical Name:
- (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile
- CAS:
- 178676-65-8
- MF:
- C13H13NO
- Structure:
- Chemical Name:
- Brivaracetam Impurity 25
- CAS:
- 10547-88-3
- MF:
- C7H12O2
- Chemical Name:
- Peramivir Impurity 19
- Chemical Name:
- NICERGOLINE IMP. D (EP): 5-BROMOPYRIDINE-3-CARBOXYLIC ACID
- Structure:
- Chemical Name:
- AMOXICILLIN TRIHYDRATE IMP. D (EP) AS SODIUM SALT:(4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]-CARBOXYMETHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID SODIUM SALT (PENICILLOICACIDS OF AMO
- CAS:
- 1642629-94-4
- MF:
- C16H21N3O6S
- Structure:
- Chemical Name:
- 4-CHLORO-6-(2-CHLORO-ETHOXY)-7-(2-METHOXY-ETHOXY)-QUINAZOLINE
- CAS:
- 183322-19-2
- MF:
- C13H14Cl2N2O3
- Structure:
- Chemical Name:
- 2-PIPERAZINE-4-AMINO-6,7-DIMETHOXY QUINOLINE HYDROCHLORIDE
- CAS:
- 84050-22-6
- MF:
- C14H20ClN5O2
- Structure:
- Chemical Name:
- 2-CHLORO-N-(2,3-DIMETHYL-PHENYL)-ACETAMIDE
- CAS:
- 2564-07-0
- MF:
- C10H12ClNO
- Structure:
- Chemical Name:
- 1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monoisopropyl ester
- CAS:
- 116983-17-6
- MF:
- C18H20N2O6
- Chemical Name:
- Cabozantinib impurity 37
- Chemical Name:
- ethyl 6-bromo-4,7-bis((dimethylamino)methyl)-5-hydroxy-1-methyl-2-((phenylthio)methyl)-1H-indole-3-carboxylate
- Chemical Name:
- Dapoxetine impurity 53
- Structure:
- Chemical Name:
- Apigenin 4'-O-(2'',6''-di-O-E-p-coumaroyl)glucoside
- CAS:
- 71781-79-8
- MF:
- C39H32O14
- Chemical Name:
- Dapoxetine impurity 70
- Structure:
- Chemical Name:
- Bosutinib Impurity 38
- CAS:
- 2095306-26-4
- MF:
- C46H44Cl4N8O6
- Structure:
- Chemical Name:
- (2RS)-2-(4-ETHYLPHENYL)PROPANOIC ACID
- CAS:
- 3585-52-2
- MF:
- C11H14O2
- Structure:
- Chemical Name:
- (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile
- CAS:
- 178676-65-8
- MF:
- C13H13NO
- Structure:
- Chemical Name:
- 3-[(2-[(E)-2-(3-ETHYL-1,3-BENZOTHIAZOL-3-IUM-2-YL)ETHENYL]-6-((E)-2-[3-ETHYL-1,3-BENZOTHIAZOL-2(3H)-YLIDENE]ETHYLIDENE)-4-METHYL-1-CYCLOHEXEN-1-YL)OXY]-1-PROPANESULFONATE
- MF:
- C32H36N2O4S3
- Chemical Name:
- Bimatoprost Impurity 15
- Structure:
- Chemical Name:
- Bisoprolol Impurity 9
- CAS:
- 59383-52-7
- MF:
- C15H25NO3
- Chemical Name:
- Empagliflozin Impurity 87
- Chemical Name:
- Amoxicillin USP Impurity M
- Structure:
- Chemical Name:
- Aztreonam Impurities 06
- CAS:
- 730928-60-6
- MF:
- C26H34N10O16S4
- Chemical Name:
- sodium (4-(2-(2-amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate
- Structure:
- Chemical Name:
- Lenvatinib Impurity LFZZ-9
- MF:
- C43H38Cl2N8O8
- Chemical Name:
- Rosuvastatin Impurity 118
- Chemical Name:
- Rosuvastatin Impurity 117
- Structure:
- Chemical Name:
- Cytarabine Impurity 10
- CAS:
- 84902-98-7
- MF:
- C4H6N2O3
- Chemical Name:
- Ticagrelor Impurity 108
- Structure:
- Chemical Name:
- 4-Piperidinecarboxylic acid, 1-[5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-3-hydroxy-2-pyridinyl]-
- CAS:
- 1290121-42-4
- MF:
- C29H35ClN6O4S2
- Structure:
- Chemical Name:
- 1,?4-?Piperazinediacetamid?e, N1,?N4-?dimethyl-?N1,?N4-?bis(4-?nitrophenyl)?-
- CAS:
- 2410649-54-4
- MF:
- C22H26N6O6
- Structure:
- Chemical Name:
- 1H-Pyrrole-3-methanamine, 1-[(1,6-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl-
- CAS:
- 2416241-95-5
- MF:
- C17H18FN3O2S
- Structure:
- Chemical Name:
- Dolutegravir Impurity 8
- CAS:
- 2244161-72-4
- MF:
- C20H19F2N3O5
- Chemical Name:
- 3-((2-((tert-butoxycarbonyl)(methyl)amino)acetoxy)methyl)-2-(((1-chloroethoxy)carbonyl)(methyl)amino)pyridine 1-oxide
- 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:
- 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
- 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:
- Abacavir
- CAS:
- 141271-12-7
- MF:
- C10H14ClN5O
- 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
- Chemical Name:
- AMIKACIN IMPURITY A
- Structure:
- Chemical Name:
- FUROSEMIDE IMPURITY A
- MF:
- C12H11ClN2O5S
- Chemical Name:
- GLICLAZIDE IMPURITY F
- Chemical Name:
- ONDANSETRON IMPURITY D
- Chemical Name:
- PERINDOPRIL IMPURITY A
- Structure:
- Chemical Name:
- (E)-Ceftiofur
- CAS:
- 120882-20-4
- MF:
- C19H17N5O7S3
- Chemical Name:
- Cefmetazole Impurity E
- Structure:
- Chemical Name:
- Azlocillin Opern-Ring Decarboxylation Impurity
- CAS:
- 99795-14-9
- MF:
- C19H25N5O5S
- Structure:
- Chemical Name:
- Cefotiam Impurity 1
- CAS:
- 2243596-87-2
- MF:
- C18H23N9O4S3
- Chemical Name:
- Eribulin Impurity 3
- 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