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:
- 3-(4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidin-1-yl)propyl 4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylate
- Structure:
- Chemical Name:
- 4-{[(4-carboxybenzyl)amino]methyl}benzoic acid
- CAS:
- 14900-61-9
- MF:
- C16H15NO4
- Structure:
- Chemical Name:
- 4-{[(4-carboxybenzyl)amino]methyl}benzoic acid
- CAS:
- 14900-61-9
- MF:
- C16H15NO4
- Structure:
- Chemical Name:
- 4-{[(4-carboxybenzyl)amino]methyl}benzoic acid
- CAS:
- 14900-61-9
- MF:
- C16H15NO4
- Structure:
- Chemical Name:
- (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(dimethylglycyl)-2,3,4,9-tetrahydro-1H-pyrido [3,4-b]indole-3-carboxylate methyl
- CAS:
- 2169996-11-4
- MF:
- C24H25N3O5
- Chemical Name:
- Fulvestrant impurity G
- Structure:
- Chemical Name:
- 2-ethoxy-1-methoxy-4-(2-(methylsulfonyl)ethyl)benzene
- MF:
- C12H18O4S
- Chemical Name:
- Bendamustine Related Impurity 17
- Chemical Name:
- Bortezomib Impurity 24
- Chemical Name:
- Bortezomib Impurity 38
- Chemical Name:
- Edoxaban Impurity 27
- Structure:
- Chemical Name:
- Linagliptin Impurity 30
- CAS:
- 2074688-81-4
- MF:
- C33H32N8O5
- Chemical Name:
- Pantoprazole Impurity 8
- Chemical Name:
- Rivaroxaban Impurity 58
- Chemical Name:
- Rivaroxaban Impurity 65
- Chemical Name:
- Sitafloxacin Impurity 4
- Chemical Name:
- Ticagrelor Related Compound 83
- Chemical Name:
- Ticagrelor Related Compound 91
- Structure:
- Chemical Name:
- 2-Hexenoic acid, 2-cyano-5-methyl-
- CAS:
- 869-02-3
- MF:
- C8H11NO2
- Structure:
- Chemical Name:
- CP-690550A
- CAS:
- 1243290-37-0
- MF:
- C15H21N5O2
- Structure:
- Chemical Name:
- (S)-Tomoxetine
- CAS:
- 105314-53-2
- MF:
- C17H21NO
- Structure:
- Chemical Name:
- Fexofenadine EP Impurity F
- CAS:
- 185066-33-5
- MF:
- C31H37NO4
- Structure:
- Chemical Name:
- (E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine
- CAS:
- 468104-18-9
- MF:
- C13H17NO
- Structure:
- Chemical Name:
- 4-(5-(pyridin-4-yl)-1H-1,2,4-triazol-3-yl)picolinamide
- CAS:
- 1992028-94-0
- MF:
- C13H10N6O
- Structure:
- Chemical Name:
- Indacaterol Impurity 22
- CAS:
- 773895-24-2
- MF:
- C31H34N2O3
- Structure:
- Chemical Name:
- 10-O-2,2-Dichloroethoxycarbonyl Docetaxe
- CAS:
- 158810-73-2
- MF:
- C46H55Cl2NO16
- Structure:
- Chemical Name:
- 4R,5S)-2,4-diphenyl-4,5-dihydrooxazole-5-carboxylic acid
- CAS:
- 849831-77-2
- MF:
- C16H13NO3
- Structure:
- Chemical Name:
- ICOFQCJKJOISKD-HSZRJFAPSA-N
- CAS:
- 1435768-96-9
- MF:
- C26H35NO3
- Structure:
- Chemical Name:
- DIHYDROCYCLOSPORIN A
- CAS:
- 59865-15-5
- MF:
- C62H113N11O12
- Structure:
- Chemical Name:
- Moxidectin
- CAS:
- 119718-45-5
- MF:
- C37H53NO8
- Structure:
- Chemical Name:
- GDZISNMJFAJFMR-BEQCQUFHSA-M
- CAS:
- 2024603-92-5
- MF:
- C58H74N2O15S
- Structure:
- Chemical Name:
- GJXNGCFWGJQETE-UHFFFAOYSA-N
- CAS:
- 1796891-27-4
- MF:
- C29H34N6O4
- Structure:
- Chemical Name:
- ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate
- CAS:
- 328283-61-0
- MF:
- C11H11Cl2NO3
- Structure:
- Chemical Name:
- Irbesartan Impurity 4
- CAS:
- 945540-26-1
- MF:
- C21H20N6O
- Structure:
- Chemical Name:
- BAUCJPGULMYPTE-UHFFFAOYSA-N
- CAS:
- 2097683-67-3
- MF:
- C24H29NO4
- Structure:
- Chemical Name:
- Entecavir Impurity 6
- CAS:
- 1354695-82-1
- MF:
- C26H27N5O3
- Structure:
- Chemical Name:
- 6-Chloro-6-defluoro Ciprofloxacin
- CAS:
- 93106-58-2
- MF:
- C17H18ClN3O3
- Structure:
- Chemical Name:
- 5-[(4-amino-2-carboxyphenyl)amino]-2-hydroxybenzoic acid
- CAS:
- 1797983-23-3
- MF:
- C14H12N2O5
- Structure:
- Chemical Name:
- 4-[1-methoxy-2-(methylamino)ethyl]benzene-1,2-diol:hydrochloride
- CAS:
- 74571-90-7
- MF:
- C10H16ClNO3
- Chemical Name:
- Vonoprazan Impurity 21
- Structure:
- Chemical Name:
- Ceftazidime Oxide Impurity
- CAS:
- 1301254-48-7
- MF:
- C22H22N6O8S2
- Structure:
- Chemical Name:
- N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(4-methoxyphenoxy)propyl)piperazin-1-yl)acetamide
- CAS:
- 1393717-46-8
- MF:
- C24H33N3O4
- Chemical Name:
- Atracurium Impurity 2
- Chemical Name:
- Blonanserin Impurity J
- Chemical Name:
- Brexpiprazole Impurity E
- Chemical Name:
- Cefazolin USP Impurity B
- Chemical Name:
- Everolimus Impurity D
- Structure:
- Chemical Name:
- Loratadine Impurity I
- CAS:
- 133330-56-0
- MF:
- C22H21ClN2O2
- Chemical Name:
- Olaparib Impurity Q
- Chemical Name:
- Ozagrel Impurity 3
- Structure:
- Chemical Name:
- Pitavastatin Impurity 12
- Structure:
- Chemical Name:
- Melphalan EP impurity H
- CAS:
- 88457-23-2
- MF:
- C14H20Cl2N2O2
- Structure:
- Chemical Name:
- ethyl 2-(4-(sec-butoxy)-3-formylphenyl)-4-methylthiazole-5- carboxylate
- CAS:
- 2375033-31-9
- MF:
- C18H21NO4S
- Structure:
- Chemical Name:
- 1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine
- CAS:
- 332374-42-2
- MF:
- C14H20N2O4S
- Structure:
- Chemical Name:
- ApovincaMinic Acid Ethyl Ester N-Oxide
- CAS:
- 109741-24-4
- MF:
- C22H26N2O3
- Chemical Name:
- Afatinib Impurity M
- Structure:
- Chemical Name:
- Ornidazole Impurity
- CAS:
- 1100750-18-2
- Structure:
- Chemical Name:
- 4-(3-nitrophenyl)-3-Morpholinone
- CAS:
- 845729-43-3
- MF:
- C10H10N2O4
- Structure:
- Chemical Name:
- 1,3-bis(2-chloroethyl)benzimidazolin-2-one
- CAS:
- 55470-74-1
- MF:
- C11H12Cl2N2O
- Chemical Name:
- Nintedanib Impurity A (Intedanib Impurity A ）
- Structure:
- Chemical Name:
- 2-Propanone, 1,3-bis(4-methoxyphenyl)-
- CAS:
- 29903-09-1
- MF:
- C17H18O3
- Structure:
- Chemical Name:
- PDXA-226
- CAS:
- 352637-51-5
- MF:
- C14H14N2O
- Structure:
- Chemical Name:
- Ropivacaine-ET-R
- CAS:
- 98626-60-9
- MF:
- C16H24N2O
- Structure:
- Chemical Name:
- Ropivacaine-iPr-S
- CAS:
- 265120-58-9
- MF:
- C17H26N2O
- Structure:
- Chemical Name:
- (S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine
- CAS:
- 1384080-33-4
- MF:
- C19H21NOS
- Structure:
- Chemical Name:
- methyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate
- MF:
- C17H15NO4S
- Chemical Name:
- Apremilast impurity 15
- Structure:
- Chemical Name:
- Aprepitant Impurity 22
- CAS:
- 934540-48-4
- MF:
- C20H16F7NO2
- Structure:
- Chemical Name:
- Aprepitant Impurity 9
- CAS:
- 219821-37-1
- MF:
- C24H25F7N4O4
- Structure:
- Chemical Name:
- Betamethasone EP Impurity I
- CAS:
- 185613-69-8
- MF:
- C22H29FO5
- Structure:
- Chemical Name:
- Canagliflozin Impurity 14
- CAS:
- 842133-17-9
- MF:
- C24H25FO5S
- Chemical Name:
- Carfilzomib Impurity F
- Structure:
- Chemical Name:
- Cefamandole Impurity A
- CAS:
- 1947364-12-6
- MF:
- C17H16N2O6S
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 19
- CAS:
- 1469910-84-6
- MF:
- C29H33ClO10
- Chemical Name:
- Docetaxel EP Impurity A
- Chemical Name:
- Empagliflozin Impurity 21
- Chemical Name:
- Febuxostat Impurity 43
- Chemical Name:
- Formoterol Impurity 20
- Chemical Name:
- Hydroxychloroquine Impurity 2
- Structure:
- Chemical Name:
- Ibrutinib Impurity 14
- CAS:
- 2417548-76-4
- MF:
- C50H48N12O4
- Chemical Name:
- Cefathiamidine Impurity D
- Chemical Name:
- Cefazolin Impurity C (EP)
- Chemical Name:
- Cefdinir Impurity H (CP)
- Chemical Name:
- Cefdinir Impurity S(CP)
- Structure:
- Chemical Name:
- Cefodizime oxidation Impurity 1
- CAS:
- 111874-11-4
- MF:
- C20H20N6O7S4
- Chemical Name:
- Spectinomycin Impurity F
- Structure:
- Chemical Name:
- (7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium
- MF:
- C29H38N5O10+
- Structure:
- Chemical Name:
- 3-pentylisobenzofuran-1(3H)-one
- CAS:
- 111943-62-5
- MF:
- C13H16O2
- Structure:
- Chemical Name:
- 2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid
- CAS:
- 2036283-13-1
- MF:
- C10H10N4O3S2
- Structure:
- Chemical Name:
- Levofloxacin Impurity 18
- CAS:
- 138998-47-7
- MF:
- C14H13F4NO3
- Chemical Name:
- N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1)
- Structure:
- Chemical Name:
- N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide
- MF:
- C18H17N5O
- Structure:
- Chemical Name:
- methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate
- CAS:
- 1616761-01-3
- MF:
- C17H23N5O3
- Chemical Name:
- Labetalol iMpurity
- CAS:
- 2731858-23-2
- Chemical Name:
- ZXANKCFSGFEBQW-PFEQFJNWSA-N
- CAS:
- 1258938-54-3
- Structure:
- Chemical Name:
- TWEORVZIMOFLDE-MXTNKPTQSA-N
- CAS:
- 1706671-50-2
- MF:
- C25H31N5O9S
- Structure:
- Chemical Name:
- WGEFOIHAXGTXJE-RTMVWDMESA-N
- CAS:
- 1373171-12-0
- MF:
- C48H61NO14
- Structure:
- Chemical Name:
- ZIMIAPVHHUISPY-CLFYSBASSA-N
- CAS:
- 866954-86-1
- MF:
- C15H15F3O5
- Structure:
- Chemical Name:
- Bis(L-Valine) Ester Ganciclovir TFA Salt
- CAS:
- 130914-71-5
- MF:
- C19H31N7O6