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.
- Structure:
- Chemical Name:Dapagliflozin Impurity 10
- CAS:461432-27-9
- MF:C21H25ClO7
- Structure:
- Chemical Name:Levetiracetam impurity 2
- CAS:1341459-52-6
- MF:C8H17N3O2
- Structure:
- Chemical Name:(S)-5-chloro-N-(3-(5-chlorothiophene-2-carboxamido)-2- hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)thiophene-2- carboxamide
- CAS:2204368-63-6
- MF:C23H21Cl2N3O5S2
- Structure:
- Chemical Name:Ezetimibe Impurity 38
- CAS:1701462-59-0
- MF:C45H58F2N2O5Si2
- Structure:
- Chemical Name:Indapamide Impurity F
- CAS:62574-66-7
- MF:C7H3Cl3O3S
- Structure:
- Chemical Name:Moxifloxacin Impurity 38
- CAS:1262758-66-6
- MF:C21H24FN3O5
- Structure:
- Chemical Name:Nimodipine Impurity 3
- CAS:101072-61-1
- MF:C11H9NO5
- Chemical Name:Pitavastatin Impurity 40
- CAS:
- MF:
- Chemical Name:Ritonavir EP Impurity R
- CAS:
- MF:
- Structure:
- Chemical Name:Ticagrelor Impurity 68
- CAS:1643378-46-4
- MF:C23H29FN6O4S
- Chemical Name:Tofacitinib Impurity 70
- CAS:
- MF:
- Chemical Name:Afatinib Impurity 22
- CAS:
- MF:
- Chemical Name:Amifostine Impurity 6
- CAS:
- MF:
- Chemical Name:Apixaban Impurity 33
- CAS:
- MF:
- Chemical Name:Aztreonam Impurity 6
- CAS:
- MF:
- Structure:
- Chemical Name:Clarithromycin Impurity EP G
- CAS:107216-09-1
- MF:C39H72N2O13
- Chemical Name:Dapagliflozin Impurity 32
- CAS:
- MF:
- Structure:
- Chemical Name:Doxofylline Impurity 7
- CAS:43135-57-5
- MF:C13H20N4O4
- Structure:
- Chemical Name:1-METHYL-5-MERCAPTOTETRAZOLE, SODIUM SALT
- CAS:51138-06-8
- MF:C2H3N4NaS
- Structure:
- Chemical Name:5-HYDROXY LANSOPRAZOLE
- CAS:131926-98-2
- MF:C16H14F3N3O3S
- Structure:
- Chemical Name:ergosteryl 3-beta-D-glucoside
- CAS:130155-33-8
- MF:C34H54O6
- Structure:
- Chemical Name:(3S,5R)-4-[5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-2-oxopyrrolidin-1-yl]-4-oxobutanoic acid
- CAS:
- MF:C22H23NO4
- Structure:
- Chemical Name:Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-4-[4-(propan-2-yloxy)-4-oxobutanamido]-2-methylbutanoate
- CAS:
- MF:C27H35NO5
- 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:4,4'-Iminodiphenol hydrochloride
- CAS:1965310-24-0
- MF:C12H12ClNO2
- Chemical Name:Cefradine Impurity D
- CAS:
- MF:
- 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: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+
- Chemical Name:Erlotinib Impurity 55
- CAS:
- MF:
- Chemical Name:Etoposide Impurity 1
- CAS:
- MF:
- Chemical Name:Etoposide Impurity 6
- CAS:
- MF:
- Chemical Name:Olaparib Impurity 34
- CAS:
- MF:
- Structure:
- Chemical Name:Oseltamivir Impurity 15
- CAS:2254819-34-4
- MF:C22H36N2O4
- Chemical Name:Oseltamivir Impurity 27
- CAS:
- MF:
- Chemical Name:Pitavastatin Impurity 20
- CAS:
- MF:
- Chemical Name:Rocuronium Bromide Impurity 20
- CAS:
- MF:
- Chemical Name:Rocuronium Bromide Impurity 9
- CAS:
- MF:
- Chemical Name:Cabozantinib Impurity H
- CAS:
- MF:
- Structure:
- Chemical Name:Clopidogrel Impurity 11
- CAS:
- MF:C15H14ClNO2S
- Structure:
- Chemical Name:Medetomidine Impurity 3
- CAS:104245-83-2
- MF:C10H13Cl
- Chemical Name:Tofacitinib Impurity 35
- CAS:
- MF:
- Structure:
- Chemical Name:Notoginsenoside FP2
- CAS:1004988-75-3
- MF:C58H98O26
- 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: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:(E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine
- CAS:1371535-54-4
- MF:C13H17NO
- Structure:
- Chemical Name:Donepezil Impurity
- CAS:896134-06-8
- MF:C17H15NO4
- Structure:
- Chemical Name:1-(2-chloro-5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
- CAS:928325-68-2
- MF:C17H15ClFN3O2S
- Structure:
- Chemical Name:N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide
- CAS:2037385-84-3
- MF:C13H19ClN4O3
- Structure:
- Chemical Name:N-(3,5-dimethylphenyl)picolinamide
- CAS:439591-67-0
- MF:C14H14N2O
- Structure:
- Chemical Name:Neratinib Impurity 6
- CAS:1144516-14-2
- MF:C26H21ClN6O4
- Structure:
- Chemical Name:Bupivacaine Impurity
- CAS:852804-30-9
- MF:C22H37N2O
- Structure:
- Chemical Name:Pseudomonic Acid D
- CAS:85248-93-7
- MF:C26H42O9
- Structure:
- Chemical Name:Terazosin Impurity
- CAS:60548-08-5
- MF:C19H25N5O4
- Structure:
- Chemical Name:1204612-29-2
- CAS:1204612-29-2
- MF:C12H18ClNO2
- Structure:
- Chemical Name:(S)-3-(dimethylamino)-1-(thiophen-3-yl)propan-1-ol
- CAS:1384080-56-1
- MF:C9H15NOS
- Structure:
- Chemical Name:BDJS-SH 4
- CAS:36588-46-2
- MF:C12H18N2O2
- Structure:
- Chemical Name:3-Chloro TirofiBan
- CAS:2713130-63-1
- MF:C22H35ClN2O5S
- Structure:
- Chemical Name:Adefovir Dipivoxil Impurity E
- CAS:116384-54-4
- MF:C10H16N5O4P
- Chemical Name:Apixaban Impurity 21
- CAS:
- MF:
- Structure:
- Chemical Name:Atorvastatin Impurity 22
- CAS:1821498-27-4
- MF:C27H30FNO6
- Structure:
- Chemical Name:Azelastine EP Impurity E
- CAS:105279-16-1
- MF:C15H9ClO2
- Chemical Name:Blonanserin impurity F
- CAS:
- MF:
- Chemical Name:Capecitabine Impurity 9
- CAS:
- MF:
- Chemical Name:Carfilzomib Impurity E
- CAS:
- MF:
- Chemical Name:Cefoxitin EP Impurity B
- CAS:
- MF:
- Chemical Name:Dabigatran Impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:Dexamethasone EP Impurity K
- CAS:1809224-82-5
- MF:C22H26O4
- Structure:
- Chemical Name:Esomeprazole Impurity 3
- CAS:1346599-85-6
- MF:C26H30N4O4S
- Structure:
- Chemical Name:FeBuxostat Impurity 41
- CAS:2428631-67-6
- MF:C19H19N3O3S
- Structure:
- Chemical Name:Formoterol EP Impurity E
- CAS:1616967-26-0
- MF:C20H26N2O4
- Chemical Name:Formoterol Impurity 16
- CAS:
- MF:
- Chemical Name:Indacaterol Impurity 11
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 14
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 19
- CAS:
- MF:
- Structure:
- Chemical Name:Isavuconazole Impurity 24
- CAS:1176988-44-5
- MF:C22H17F2N5OS
- Chemical Name:Letrozole Impurity 10
- CAS:
- MF: