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:
- Lincomycin EP Impurity B
- CAS:
- 37744-65-3
- MF:
- C18H32N2O6S
- Structure:
- Chemical Name:
- Roxithromycin EP Impurity D
- CAS:
- 134931-00-3
- MF:
- C41H76N2O15
- Structure:
- Chemical Name:
- 2-(pentan-3-yloxy)acetaldehyde
- CAS:
- 1141364-90-0
- MF:
- C7H14O2
- Structure:
- Chemical Name:
- Abiraterone Impurity 10
- CAS:
- 165334-69-0
- MF:
- C26H33NO2
- Chemical Name:
- Cabozantinib Impurity B
- Structure:
- Chemical Name:
- (R)-5-(2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-amine
- CAS:
- 1223404-88-3
- MF:
- C16H15F2N5
- Structure:
- Chemical Name:
- Pinocembrin 7-O-beta-D-glucoside
- CAS:
- 75829-43-5
- MF:
- C21H22O9
- Structure:
- Chemical Name:
- Ceftazidime Ep Impurity H
- CAS:
- 1354396-23-8
- MF:
- C23H24N6O7S2
- Structure:
- Chemical Name:
- Parecoxib Sodium Impurity 14
- CAS:
- 1709956-89-7
- MF:
- C19H18N2O4S
- Structure:
- Chemical Name:
- tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate
- CAS:
- 1651214-74-2
- MF:
- C29H37N7O4
- Structure:
- Chemical Name:
- Prasugrel Impurity 4 HCl
- CAS:
- 1618107-96-2
- MF:
- C20H22Cl2FNO3S
- Structure:
- Chemical Name:
- 2-AMINO-3,5-DIBROMOBENZENE-1-CARBOHYDRAZIDE
- CAS:
- 97096-13-4
- MF:
- C7H7Br2N3O
- Structure:
- Chemical Name:
- Trityl losartan
- CAS:
- 133909-99-6
- MF:
- C41H37ClN6O
- Structure:
- Chemical Name:
- Cefmetazole Lactone
- CAS:
- 70993-70-3
- MF:
- C13H13N3O5S2
- Chemical Name:
- Canagliflozin Impurity 19
- Chemical Name:
- Canagliflozin Impurity 24
- Chemical Name:
- Carfilzomib Impurity 5
- Structure:
- Chemical Name:
- Ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3- (1-ethylpropoxy)cyclohexanecarboxylate
- CAS:
- 2124269-41-4
- MF:
- C16H29N5O4
- Structure:
- Chemical Name:
- Dolutegravir Impurity 6
- CAS:
- 1357289-29-2
- MF:
- C20H19F2N3O5
- Chemical Name:
- Febuxostat Impurity 22
- Chemical Name:
- Istradefylline Impurity C
- Structure:
- Chemical Name:
- Everolimus O-Ethyl Impurity
- CAS:
- 1704711-12-5
- MF:
- C54H85NO14
- Structure:
- Chemical Name:
- (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine
- CAS:
- 324023-99-6
- MF:
- C20H23NO3
- Structure:
- Chemical Name:
- Solifenacin Impurity 4（Solifenacin EP Impurity H）
- CAS:
- 732228-02-3
- MF:
- C23H26N2O2
- Structure:
- Chemical Name:
- 849217-77-2
- CAS:
- 849217-77-2
- MF:
- C22H20N2O6
- Structure:
- Chemical Name:
- 1-Piperidinepropanoic acid, 4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-, ethyl ester, (3R,4R)-
- CAS:
- 1675248-18-6
- MF:
- C18H25N5O3
- Structure:
- Chemical Name:
- Amlodipine iMpurity L
- CAS:
- 1821498-25-2
- MF:
- C17H19ClN2O5
- Structure:
- Chemical Name:
- (6R,7R)-7-[(2,2-dimethylpropanoyl)amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- CAS:
- 2384108-14-7
- MF:
- C16H20N4O4S3
- Structure:
- Chemical Name:
- methyl (41R,12R,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:
- 58000-63-8
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- (S)-ethyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate
- CAS:
- 1392015-05-2
- MF:
- C17H15F5NO5P
- Structure:
- Chemical Name:
- N-(2-(dimethylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide
- CAS:
- 2044702-39-6
- MF:
- C25H26N6O2
- Structure:
- Chemical Name:
- 3-(2-cyclopentylidene-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
- MF:
- C19H26BrNO2
- Structure:
- Chemical Name:
- Apixaban Impurity 16
- CAS:
- 1619934-76-7
- MF:
- C31H37N5O6
- Structure:
- Chemical Name:
- Cephalexin Impurity 3
- MF:
- C16H17N3O4S
- Structure:
- Chemical Name:
- (6R,7R)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-pivalamido-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- CAS:
- 1798390-48-3
- MF:
- C16H20N4O4S3
- Structure:
- Chemical Name:
- Bupivacaine Impurity
- CAS:
- 780736-98-3
- MF:
- C14H20N2O
- Structure:
- Chemical Name:
- rel-(4aR,7aR)-6-Benzyloctahydro-1H-pyrrolo[3,4-b]pyridine
- CAS:
- 161594-54-3
- MF:
- C14H20N2
- Structure:
- Chemical Name:
- 1,2-bis(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethane
- CAS:
- 51299-16-2
- MF:
- C24H28F6N4
- Structure:
- Chemical Name:
- (R)-N-(1-(7,8-dihydronaphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine
- CAS:
- 802918-35-0
- MF:
- C22H24F3N
- Structure:
- Chemical Name:
- Demiditraz racemate
- CAS:
- 944263-08-5
- MF:
- C13H16N2
- Structure:
- Chemical Name:
- Ropivacaine-iPr
- CAS:
- 175888-75-2
- MF:
- C17H26N2O
- Structure:
- Chemical Name:
- Demiditraz IMpurity
- CAS:
- 944267-48-5
- MF:
- C19H18N2O
- Structure:
- Chemical Name:
- Apremilast impurity 18
- CAS:
- 1407140-51-5
- MF:
- C20H32N2O6S
- Structure:
- Chemical Name:
- Betamethasone EP Impurity F
- CAS:
- 330157-04-5
- MF:
- C22H28O4
- Chemical Name:
- Capecitabine Impurity 8
- Chemical Name:
- Carfilzomib Impurity D
- Chemical Name:
- Cefodizime Impurity 4
- Structure:
- Chemical Name:
- Cefradine impurity 5
- CAS:
- 1379292-16-6
- MF:
- C10H17NO2
- Structure:
- Chemical Name:
- Clopidogrel Impurity 13
- CAS:
- 2173294-69-2
- MF:
- C16H16ClNO5S2
- Chemical Name:
- DecitaBine Impurity 12
- Chemical Name:
- Erlotinib Impurity 28
- Structure:
- Chemical Name:
- Fosaprepitant Impurity 12
- CAS:
- 172673-19-7
- MF:
- C23H22F7N4O6P
- Structure:
- Chemical Name:
- Ibuprofen Impurity 2
- MF:
- C13H18O2
- Chemical Name:
- Letrozole Impurity
- Structure:
- Chemical Name:
- Alogliptin Impurity C
- CAS:
- 1108731-49-2
- MF:
- C20H23N5O3
- Chemical Name:
- Parecoxib Impurity J
- Structure:
- Chemical Name:
- 6-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(2-oxo-1,2-dihydroquinolin-7-yloxy)butyl)quinolin-2(1H)-one
- MF:
- C38H40N4O4S
- Chemical Name:
- Atracurium Impurity F
- Chemical Name:
- Linagliptin Impurity J
- Chemical Name:
- Linagliptin Impurity Q
- Structure:
- Chemical Name:
- (R)-2-(((1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)amino)methyl)-4-fluorobenzonitrile
- MF:
- C26H24F2N6O2
- Chemical Name:
- Rosuvastatin Calcium Impurity
- Chemical Name:
- Canagliflozin Monoacetyl Impurity
- Structure:
- Chemical Name:
- Etoricoxib Impurity 13
- CAS:
- 1817735-82-2
- MF:
- C25H20ClN3O3S
- Structure:
- Chemical Name:
- Mirabegron Impurity 11
- CAS:
- 1684452-85-4
- MF:
- C21H24N4O2S
- Chemical Name:
- Riociguat Impurtiy 2
- Structure:
- Chemical Name:
- Topiroxostat Impurity 9
- CAS:
- 577778-82-6
- MF:
- C13H8N6O
- Chemical Name:
- Vonoprazan Impurity F
- Structure:
- Chemical Name:
- Vortioxetine Impurity 15
- CAS:
- 2099147-02-9
- MF:
- C28H34N4S2
- Chemical Name:
- Dapagliflozin Impurity H
- Chemical Name:
- Dapoxetine Impurity C
- Chemical Name:
- Eltrombopag Impurity 4
- Chemical Name:
- Iodixanol Impurity
- Structure:
- Chemical Name:
- Levothyroxine EP Impurity B
- CAS:
- 1628720-66-0
- MF:
- C15H11ClI3NO4
- Chemical Name:
- Ribavirin Imp. EP)
- Structure:
- Chemical Name:
- Sertraline EP Impurity
- MF:
- C17H17Cl2N
- Structure:
- Chemical Name:
- Vildagliptin Related Compound G
- CAS:
- 1616662-84-0
- MF:
- C12H20N4O3
- Structure:
- Chemical Name:
- 3-ethyl 5-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
- CAS:
- 158151-92-9
- MF:
- C22H29ClN2O5
- Structure:
- Chemical Name:
- Methyl 3-acetamido-4-(2,4,5-trifluorophenyl)but-2-enoate
- CAS:
- 1234321-81-3
- MF:
- C13H12F3NO3
- Structure:
- Chemical Name:
- Cycloastragenol-6-O-β-D-glucoside
- CAS:
- 86764-12-7
- MF:
- C36H60O10
- Structure:
- Chemical Name:
- FG-4592 intermediate 8
- CAS:
- 1509958-20-6
- MF:
- C20H17NO6
- Chemical Name:
- Parecoxib Sodium Imp.E
- Chemical Name:
- Imatinib Impurity 9
- Chemical Name:
- Isavuconazole Impurity 22
- Chemical Name:
- Isavuconazole Impurity 28
- Structure:
- Chemical Name:
- Levothyroxine Impurity 16
- CAS:
- 909279-46-5
- MF:
- C15H11ClI3NO4
- Chemical Name:
- Linagliptin Impurity 42
- Chemical Name:
- PalBociclib Impurity 25
- Structure:
- Chemical Name:
- Posaconazole Impurity 13
- CAS:
- 357189-98-1
- MF:
- C37H40F2N8O6
- Structure:
- Chemical Name:
- Posaconazole Impurity 25
- CAS:
- 1042398-26-4
- MF:
- C16H19F2IO3
- Structure:
- Chemical Name:
- Posaconazole Impurity 42
- CAS:
- 357189-96-9
- MF:
- C36H40F2N8O5
- Chemical Name:
- Posaconazole Impurity 65
- Structure:
- Chemical Name:
- Pramipexole Dimer Impurity (Mixture of Diastereomers)
- CAS:
- 1147937-31-2
- MF:
- C13H23N3S
- Chemical Name:
- Sitafloxacin Impurity 1
- Chemical Name:
- Sitagliptin Impurity 25
- Chemical Name:
- sofosBuvir impurity 47
- Chemical Name:
- SofosBuvir Impurity 64
- Chemical Name:
- Tofacitinib Impurity W
- Chemical Name:
- Trelagliptin Impurity 21