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:
- N-tert-Butoxycarbonyl Mirabegron
- CAS:
- 1329485-55-3
- MF:
- C26H32N4O4S
- Structure:
- Chemical Name:
- alpha-Hydroxy-alpha-phenylbenzeneacetic acid (3-endo)-8-azabicyclo[3.2.1]oct-3-yl ester hydrochloride
- CAS:
- 63516-30-3
- MF:
- C21H24ClNO3
- Structure:
- Chemical Name:
- N-(4-(METHYLAMINO)BENZOYL)-L-GLUTAMIC ACID
- CAS:
- 52980-68-4
- MF:
- C13H16N2O5
- Structure:
- Chemical Name:
- (2R)-N-(2,6-DIMETHYLPHENYL)-2-PIPERIDINECARBOXAMIDE
- CAS:
- 27262-43-7
- MF:
- C14H20N2O
- Structure:
- Chemical Name:
- ICARISIDE B5
- CAS:
- 114226-08-3
- MF:
- C19H32O8
- Structure:
- Chemical Name:
- CLARITHROMYCIN OXIME
- CAS:
- 127253-06-9
- MF:
- C38H70N2O13
- Structure:
- Chemical Name:
- PYRIDINE,3,5-BIS(BROMOMETHYL)-
- CAS:
- 35991-75-4
- MF:
- C7H7Br2N
- Structure:
- Chemical Name:
- 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid(Anagrelide Impurity B)
- CAS:
- 1159977-03-3
- MF:
- C10H9Cl2N3O2
- Structure:
- Chemical Name:
- Aids004544
- CAS:
- 145397-25-7
- MF:
- C8H10FN3O4
- Structure:
- Chemical Name:
- Phosphine oxide, tris (2-methylphenyl)-
- CAS:
- 6163-63-9
- MF:
- C21H21OP
- Structure:
- Chemical Name:
- 2-(7-Methoxynaphthalen-1-yl)acetamide
- CAS:
- 138113-07-2
- MF:
- C13H13NO2
- Structure:
- Chemical Name:
- 2-(2-carboxyethyl)-1-[(3,4-dimethoxyphenyl)methyl]-,1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-isoquinolinium benzenesulfonate
- CAS:
- 1075727-06-8
- MF:
- C30H37NO9S
- Structure:
- Chemical Name:
- 1,2,4-Triazolo[4,3-a]pyrazine, 7-[3-amino-1-oxo-4-(2,4,5-trifluorophenyl)-2-butenyl]-5,6,7,8-tetrahydro- 3-(trifluoromethyl)-
- CAS:
- 847445-81-2
- MF:
- C16H13F6N5O
- Structure:
- Chemical Name:
- 4-Difluoromethoxy-2-nitro-aniline
- CAS:
- 97963-76-3
- MF:
- C7H6F2N2O3
- Chemical Name:
- Tigecycline Impurity 6
- Structure:
- Chemical Name:
- Febuxostat Bromo Impurity
- CAS:
- 144060-40-2
- MF:
- C15H16BrNO3S
- Structure:
- Chemical Name:
- Meptazinol Impurity
- CAS:
- 1314003-47-8
- MF:
- C23H28N2O4
- Structure:
- Chemical Name:
- 1'H-2,3'-bipyridinyl-2'-one
- CAS:
- 101002-01-1
- MF:
- C10H8N2O
- Chemical Name:
- Brexpiprazole Impurity D
- Chemical Name:
- Brivaracetam Impurity E
- Chemical Name:
- Dapoxetine Impurity 8
- Structure:
- Chemical Name:
- Irbesartan Impurity 6
- MF:
- C25H28N6O
- Chemical Name:
- Empagliflozin impurity B
- Chemical Name:
- Varenicline Impurity 1
- Chemical Name:
- Voriconazole Impurity 6
- Chemical Name:
- Caspofungin impurity 1
- Chemical Name:
- Cabozantinib impurity D
- Chemical Name:
- Neratinib Impurity 3
- Structure:
- Chemical Name:
- Ranitidine Impurity D
- MF:
- C13H22N4O3S
- Structure:
- Chemical Name:
- Metoprolol IMpurity 5
- MF:
- C15H25NO3
- Chemical Name:
- Mirabegron Impurity 2
- Structure:
- Chemical Name:
- Pemetrexed Impurity 1
- CAS:
- 1644287-26-2
- MF:
- C20H21N5O8
- Chemical Name:
- Plerixafor Impurity B
- Chemical Name:
- Tolvaptan impurity3
- Chemical Name:
- Vonoprazan Impurity 7
- Chemical Name:
- Cefazolin impurity F
- Structure:
- Chemical Name:
- Apremilast Impurity 3
- CAS:
- 88687-92-7
- MF:
- C16H10N2O8
- Structure:
- Chemical Name:
- Apixaban Impurity 8
- CAS:
- 1777781-49-3
- MF:
- C24H23N5O4
- Chemical Name:
- Ritodrine BP Impurity D
- Chemical Name:
- Rivaroxaban Impurity 19
- Structure:
- Chemical Name:
- Topiroxostat Impurity 4
- CAS:
- 1379342-46-7
- MF:
- C8H8N2O3
- Chemical Name:
- Ertapenem impurity 1
- Structure:
- Chemical Name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate
- MF:
- C26H36NO3
- Chemical Name:
- Flomoxef Impurity 3
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1105704-96-8
- MF:
- C12H14N2O3
- Structure:
- Chemical Name:
- Agomelatine Impurity 1
- CAS:
- 1352139-51-5
- MF:
- C15H19NO2
- Structure:
- Chemical Name:
- Diquafosol Impurity 1
- CAS:
- 26184-65-6
- MF:
- C18H24N4O17P2
- Structure:
- Chemical Name:
- Milnacipran Impurity 3
- CAS:
- 1353644-50-4
- MF:
- C15H20ClNO
- Structure:
- Chemical Name:
- L-Glutamic acid 1-ethyl ester
- CAS:
- 52454-78-1
- MF:
- C7H13NO4
- Structure:
- Chemical Name:
- Methyl 2-Hydroxy-2-(Thiophen-2-Yl)-2-(Thiophen-3-Yl)Acetate
- CAS:
- 28748-67-6
- MF:
- C11H10O3S2
- Structure:
- Chemical Name:
- 6,7-Dihydro-N-methyl-N-[(3R,4R)-4-methyl-3-piperidinyl]-5H-pyrrolo[2,3-d]pyrimidin-4-amine
- CAS:
- 1812890-23-5
- MF:
- C13H21N5
- Structure:
- Chemical Name:
- Sacubitril Impurity 72
- CAS:
- 1361408-16-3
- MF:
- C23H27NO4
- Structure:
- Chemical Name:
- (1R,2S,3R)-Aprepitant
- CAS:
- 1185502-97-9
- MF:
- C23H21F7N4O3
- Structure:
- Chemical Name:
- Clemastine
- CAS:
- 108825-05-4
- MF:
- C21H26ClNO2
- 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
- Structure:
- Chemical Name:
- 3-Pyridinecarboxylic acid, 6-(4-carboxy-1-piperidinyl)-5-chloro-
- CAS:
- 958457-83-5
- MF:
- C12H13ClN2O4
- Chemical Name:
- Linagliptin Impurity C
- Chemical Name:
- Parecoxib Impurity B
- Chemical Name:
- Vildagliptin impurity E
- Structure:
- Chemical Name:
- 3-propylisobenzofuran-1(3H)-one
- CAS:
- 72424-08-9
- MF:
- C11H12O2
- Structure:
- Chemical Name:
- Axitinib Sulfonyl
- CAS:
- 1348536-59-3
- MF:
- C22H18N4O3S
- Chemical Name:
- Atracurium Impurity B
- CAS:
- 87046-74-0
- Structure:
- Chemical Name:
- (R)-4-fluoro-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
- MF:
- C23H24FN7O4
- Structure:
- Chemical Name:
- 2-(2-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol
- MF:
- C13H13FN6O
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 10
- CAS:
- 960404-86-8
- MF:
- C21H25ClO7
- Structure:
- Chemical Name:
- Ibrutinib Impurity 6
- CAS:
- 1917333-91-5
- MF:
- C28H26N6O3
- Chemical Name:
- Imatinib Impurity 5
- Structure:
- Chemical Name:
- Mirabegron Impurity 8 HCl
- CAS:
- 1684452-81-0
- MF:
- C21H24N4O2S
- Chemical Name:
- Regorafenib Impurity 2
- Chemical Name:
- Vonoprazan Impurity 5
- Structure:
- Chemical Name:
- Bendamustine
- CAS:
- 1219709-86-0
- MF:
- C14H18ClN3O2
- Chemical Name:
- Dapagliflozin Impurity E
- Structure:
- Chemical Name:
- Febuxostat Impurity 14
- CAS:
- 1335202-60-2
- MF:
- C15H16N2OS
- Structure:
- Chemical Name:
- Kaempferol 3-robinoside 7-glucoside
- CAS:
- 114924-89-9
- MF:
- C33H40O20
- Structure:
- Chemical Name:
- Vitexin 7-glucoside
- CAS:
- 35109-95-6
- MF:
- C27H30O15
- 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:
- 4-chloro-7-methoxyquinoline-6-carboxylic acid
- CAS:
- 771464-30-3
- MF:
- C11H8ClNO3
- Structure:
- Chemical Name:
- ethyl (41S,13aR)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:
- 85647-43-4
- MF:
- C22H26N2O2
- Structure:
- Chemical Name:
- methyl (41R,12R,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:
- 38990-16-8
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- Dolutegravir Impurity 3
- CAS:
- 1973402-05-9
- MF:
- C20H19F2N3O5
- Structure:
- Chemical Name:
- Cistracurium Besylate EP Impurity D
- CAS:
- 1075726-88-3
- MF:
- C31H39NO9S
- Structure:
- Chemical Name:
- (R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-3-chloropropan-1-one
- CAS:
- 1288338-96-4
- MF:
- C25H25ClN6O2
- Structure:
- Chemical Name:
- Bendamustine Impurity 8
- CAS:
- 1797881-48-1
- MF:
- C14H19Cl2N3O2
- Structure:
- Chemical Name:
- FeBuxostat Impurity 32
- CAS:
- 1805770-41-5
- MF:
- C12H12N2O
- Structure:
- Chemical Name:
- Edoxaban Impurity 9(1R,2S,4S)
- CAS:
- 2024614-15-9
- MF:
- C21H30ClN5O5
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 22
- CAS:
- 1350288-77-5
- MF:
- C19H18ClN3O5S
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 27
- CAS:
- 1369969-44-7
- MF:
- C21H21N3O5
- Structure:
- Chemical Name:
- Abiraterone Impurity 9
- CAS:
- 165334-72-5
- MF:
- C24H31NO
- Chemical Name:
- Gliclazide Impurity A
- Structure:
- Chemical Name:
- Medetomidine Impurity 14
- CAS:
- 79924-14-4
- MF:
- C13H16N2
- Structure:
- Chemical Name:
- Tenofovir Disoproxil Impurity B
- CAS:
- 36817-69-3
- MF:
- C8H11N5O
- Chemical Name:
- Ipragliflozin IMP