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:
- 2-amino-9-((1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one
- CAS:
- 1367369-77-4
- MF:
- C12H15N5O3
- Chemical Name:
- Carfilzomib Impurity B
- Structure:
- Chemical Name:
- Hesperidin dihydrochalcone
- CAS:
- 35573-79-6
- MF:
- C28H36O15
- Structure:
- Chemical Name:
- Alogliptin Imp.12
- CAS:
- 2749281-73-8
- MF:
- C25H25N5O3
- Structure:
- Chemical Name:
- Ornidazole Impurity 1
- CAS:
- 1100750-18-2
- Structure:
- Chemical Name:
- Norpterosin B glucoside
- CAS:
- 1226785-88-1
- MF:
- C19H26O7
- Structure:
- Chemical Name:
- (1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate
- CAS:
- 229614-51-1
- MF:
- C16H30N4O4
- Structure:
- Chemical Name:
- Bis(4-fluorobenzyl)aMine, 97%
- CAS:
- 134227-41-1
- MF:
- C14H13F2N
- Structure:
- Chemical Name:
- (3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester
- CAS:
- 1292296-09-3
- MF:
- C38H52N6O7
- Structure:
- Chemical Name:
- L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride
- CAS:
- 142963-69-7
- MF:
- C14H23ClN6O4
- Structure:
- Chemical Name:
- 8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride
- CAS:
- 432543-89-0
- MF:
- C19H20Cl2N2
- Structure:
- Chemical Name:
- 1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide
- CAS:
- 141745-71-3
- MF:
- C25H29N3O2
- Structure:
- Chemical Name:
- PF 2825
- CAS:
- 153012-65-8
- MF:
- C21H28N2O5S
- Structure:
- Chemical Name:
- 3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride
- CAS:
- 444057-64-1
- MF:
- C24H27ClN4O6S2
- Structure:
- Chemical Name:
- Ertapenem Dimer Form D Impurity
- CAS:
- 1199797-41-5
- MF:
- C44H50N6O14S2
- Structure:
- Chemical Name:
- S 00218
- CAS:
- 92700-82-8
- MF:
- C15H22N2O4
- Structure:
- Chemical Name:
- 2-Methyl-2-(4-vinylphenyl)propanoic acid
- CAS:
- 1256584-72-1
- MF:
- C12H14O2
- Structure:
- Chemical Name:
- Loratadine IMpurity D
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- PeMetrexed EP IMpurity A
- CAS:
- 869791-42-4
- MF:
- C21H23N5O6
- Chemical Name:
- Itraconazole EP IMpurity G
- Structure:
- Chemical Name:
- (1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride
- CAS:
- 1402222-66-5
- MF:
- C9H10ClF2N
- Structure:
- Chemical Name:
- IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine
- CAS:
- 216581-01-0
- MF:
- C30H30N2
- Structure:
- Chemical Name:
- 21-Dehydro-6α-Methyl Prednisolone
- CAS:
- 58636-50-3
- MF:
- C22H28O5
- Structure:
- Chemical Name:
- α-Hydroxy Flurbiprofen
- CAS:
- 61466-95-3
- MF:
- C15H13FO3
- Structure:
- Chemical Name:
- 5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate
- CAS:
- 1391194-45-8
- MF:
- C20H21NO3S
- Structure:
- Chemical Name:
- 9-AcridinaMine, 6-chloro-2-ethoxy-
- CAS:
- 855939-48-9
- MF:
- C15H13ClN2O
- Structure:
- Chemical Name:
- 1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone
- CAS:
- 221615-72-1
- MF:
- C15H15NOS
- Structure:
- Chemical Name:
- Edaravone
- CAS:
- 68195-63-1
- MF:
- C30H26N6O3
- Structure:
- Chemical Name:
- Caspofungin IMpurity A
- CAS:
- 1202167-57-4
- MF:
- C51H86N10O15
- Structure:
- Chemical Name:
- DesdifluoroMethoxy Hydroxy Pantoprazole
- CAS:
- 1261238-06-5
- MF:
- C15H15N3O4S
- Structure:
- Chemical Name:
- Levofloxacin Hydroxy Acid
- CAS:
- 1036016-10-0
- MF:
- C18H21F2N3O4
- Structure:
- Chemical Name:
- N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine
- CAS:
- 91147-43-2
- MF:
- C11H11N5
- Structure:
- Chemical Name:
- Nor Lidocaine Hydrochloride
- CAS:
- 7729-94-4
- MF:
- C12H19ClN2O
- Structure:
- Chemical Name:
- rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate
- CAS:
- 136310-66-2
- MF:
- C18H19NO3S2
- Structure:
- Chemical Name:
- (11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one
- CAS:
- 709615-25-8
- MF:
- C30H37NO4
- Structure:
- Chemical Name:
- 4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid
- CAS:
- 1187954-57-9
- MF:
- C32H37NO3
- Structure:
- Chemical Name:
- (2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride
- CAS:
- 1370331-33-1
- MF:
- C8H17NO5
- Structure:
- Chemical Name:
- (3S,5R)-Rosuvastatin
- CAS:
- 1242184-42-4
- MF:
- C22H28FN3O6S
- Structure:
- Chemical Name:
- (S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide
- CAS:
- 119714-13-5
- MF:
- C10H16N2O3S
- Structure:
- Chemical Name:
- Afatinib IMpurity I
- CAS:
- 1637254-93-3
- MF:
- C22H19BrClFN4O3
- Structure:
- Chemical Name:
- Aripiprazole iMpurity 2
- CAS:
- 1424857-93-1
- MF:
- C14H18Cl2N2
- Chemical Name:
- Avanafil IMpurity 6
- Chemical Name:
- Cefoxitin iMpurity F (S-Methoxy cefoxitin)
- Structure:
- Chemical Name:
- Clopidogrel IMpurity 1
- MF:
- C15H14ClNO2S
- Chemical Name:
- LincoMycin iMpurity A
- Chemical Name:
- Posaconazole iMpurity 1
- Chemical Name:
- Riociguat IMpurtiy
- CAS:
- 2920299-23-4
- Chemical Name:
- TelMisartan IMpurity E
- Structure:
- Chemical Name:
- IverMectin B1 Mono-sugar Derivative
- CAS:
- 71837-27-9
- MF:
- C41H62O11
- Structure:
- Chemical Name:
- Desethyl Acetate (E)-CefuroxiMe Axetil
- CAS:
- 97232-97-8
- MF:
- C16H16N4O8S
- Structure:
- Chemical Name:
- 6-AMino-5-azacytidine
- CAS:
- 105331-00-8
- MF:
- C8H13N5O5
- Structure:
- Chemical Name:
- N-Methyl-3-phenylpropan-1-aMine hydrochloride (RelCpd B)
- CAS:
- 30684-07-2
- MF:
- C10H16ClN
- Structure:
- Chemical Name:
- 1-[2-[(2,6-diMethylphenyl)thio]phenyl]- Piperazine
- CAS:
- 508233-76-9
- MF:
- C18H22N2S
- Structure:
- Chemical Name:
- 1-NaphthaleneMethanaMine, α-Methyl-N-[[3-(trifluoroMethyl)phenyl]Methyl]-, (αR)-
- CAS:
- 1229512-52-0
- MF:
- C20H18F3N
- Chemical Name:
- Bisoprolol Impurity 34
- Chemical Name:
- Flomoxef Impurity I
- Chemical Name:
- Lasmiditan Impurity 5
- Chemical Name:
- Olodaterol Impurity 18
- CAS:
- 2727170-18-3
- Chemical Name:
- Febuxostat impurity DAC
- Structure:
- Chemical Name:
- ETHYL1-METHYL-2-OXOCYCLOPENTANECARBOXYLATE
- CAS:
- 5453-88-3
- MF:
- C9H14O3
- Chemical Name:
- Olodaterol Impurity 27
- Chemical Name:
- (R)-Fluvastatin EP Impurity E
- Chemical Name:
- Ethacridine Impurity 9
- Chemical Name:
- isopropyl 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate
- Chemical Name:
- 32,50-Dicarboxy-cyanoco balamin
- Chemical Name:
- Olodaterol Impurity 30
- Structure:
- Chemical Name:
- Avatrombopag Impurity 55
- CAS:
- 1039808-70-2
- MF:
- C14H16Cl2N2O3
- Structure:
- Chemical Name:
- 3-(2-Aminoethyl)-N-methyl-1H-indole-5-methanesulfonamide
- CAS:
- 88919-22-6
- MF:
- C12H17N3O2S
- Structure:
- Chemical Name:
- 3'-Epi Gemcitabine
- CAS:
- 103882-85-5
- MF:
- C9H11F2N3O4
- Structure:
- Chemical Name:
- 4-Chloro-6,7-bis-(2-chloroethoxy)quinazoline
- CAS:
- 183322-21-6
- MF:
- C12H11Cl3N2O2
- Structure:
- Chemical Name:
- 4-Hydroxy Omeprazole
- CAS:
- 301669-82-9
- MF:
- C16H17N3O3S
- Structure:
- Chemical Name:
- Benzonitrile, 2-[[4-[(3R)-3-amino-1-piperidinyl]-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl]methyl]-
- CAS:
- 1634664-96-2
- MF:
- C17H19N5O2
- Structure:
- Chemical Name:
- 2-(3,4-dihydroxyphenyl)-2-hydroxy-acetaldehyde
- CAS:
- 13023-73-9
- MF:
- C8H8O4
- Structure:
- Chemical Name:
- 3-Desmethyl Istradefylline
- CAS:
- 155272-04-1
- MF:
- C19H22N4O4
- Structure:
- Chemical Name:
- BRN 0758154
- CAS:
- 69304-48-9
- MF:
- C11H13IN2O5
- Structure:
- Chemical Name:
- NSC4751
- CAS:
- 5393-61-3
- MF:
- C10H10N2O2
- Structure:
- Chemical Name:
- Sts 64
- CAS:
- 24284-84-2
- MF:
- C21H27NO2
- Structure:
- Chemical Name:
- 2-hydroxy-N-[3-[3-(1-piperidylmethyl)phenoxy]propyl]acetamide
- CAS:
- 97900-88-4
- MF:
- C17H26N2O3
- Structure:
- Chemical Name:
- 2-Cyclopentene-1-carboxylicacid,4-amino-,methylester,(1R,4S)-(9CI)
- CAS:
- 352226-74-5
- MF:
- C7H11NO2
- Chemical Name:
- Tamsulosin N- methyl benzyl Impurity
- Chemical Name:
- Oprinone Impurity 7
- Chemical Name:
- Arbidol Impurity 27
- Structure:
- Chemical Name:
- N-methyl-5,6-dihydroxyindole
- CAS:
- 4821-00-5
- MF:
- C9H9NO2
- Chemical Name:
- Imimidistine impurity G
- Structure:
- Chemical Name:
- 4-amino-5-chloro-2-ethoxy-N-((2-morpholinyl)methyl)benzamide
- CAS:
- 152013-26-8
- MF:
- C14H20ClN3O3
- Structure:
- Chemical Name:
- cleistanthin B
- CAS:
- 30021-77-3
- MF:
- C27H26O12
- Structure:
- Chemical Name:
- phosphoric acid
- CAS:
- 790712-60-6
- MF:
- C16H18F6N5O5P
- Structure:
- Chemical Name:
- 4-(4-AMINO-3-FLUOROPHENOXY)-N-METHYLPICOLINAMIDE
- CAS:
- 757251-39-1
- MF:
- C13H12FN3O2
- Structure:
- Chemical Name:
- 4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one (Loratadine Impurity)
- CAS:
- 133330-60-6
- MF:
- C14H9Cl2NO
- Structure:
- Chemical Name:
- Hydroxy Varenicline
- CAS:
- 357424-21-6
- MF:
- C13H13N3O
- Structure:
- Chemical Name:
- ethyl (2S)-pyrrolidine-2-carboxylate
- CAS:
- 5817-26-5
- MF:
- C7H13NO2
- Structure:
- Chemical Name:
- [2R-[2aR*),3a]-2-[1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine
- CAS:
- 170729-79-0
- MF:
- C20H18F7NO2
- Structure:
- Chemical Name:
- Benzoic acid, 2-[[[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]aMino]carbonyl]-
- CAS:
- 1365267-37-3
- MF:
- C22H21N3O7
- Structure:
- Chemical Name:
- NSC 609249
- CAS:
- 51012-67-0
- MF:
- C12H20ClNO2
- Chemical Name:
- Doxorubicin Impurity 6
- CAS:
- 69429-21-6
- MF:
- C26H27NO11
- Structure:
- Chemical Name:
- Etoricoxib Impurity 11
- CAS:
- 202409-31-2
- MF:
- C17H13ClN2O2S
- Structure:
- Chemical Name:
- Levofloxacin Tetrafluoro Impurity 1
- CAS:
- 110548-02-2
- MF:
- C15H15F4NO4
- Structure:
- Chemical Name:
- Penicillin F Potassium Salt
- CAS:
- 97299-13-3
- MF:
- C14H21KN2O4S
- Structure:
- Chemical Name:
- Olaparib Impurity 31
- CAS:
- 458535-34-7
- MF:
- C12H18N2O2
- Structure:
- Chemical Name:
- Macitentan impurity A
- CAS:
- 441798-25-0
- MF:
- C17H16Br2N6O4S