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-Thiazolamine, 4-(4-bromo-2-thienyl)-
- CAS:
- 81216-89-9
- MF:
- C7H5BrN2S2
- Structure:
- Chemical Name:
- GADOTERIDOL RELATED COMPOUND B (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT)
- CAS:
- 112188-16-6
- MF:
- C14H22GdN4O6
- Structure:
- Chemical Name:
- Elagolix Sodium impurity4
- CAS:
- 2248628-92-2
- MF:
- C19H21NO4S
- Chemical Name:
- Tadalafil Impurity 45
- Structure:
- Chemical Name:
- (R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol
- MF:
- C28H28O3
- Structure:
- Chemical Name:
- (trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol
- MF:
- C13H18Br2N2O
- Chemical Name:
- Edaravone Impurity
- Structure:
- Chemical Name:
- 1-Butanesulfonic acid, 4-hydroxy-, methyl ester
- CAS:
- 343928-18-7
- MF:
- C5H12O4S
- Chemical Name:
- Fesoterodine Impurity 17
- Structure:
- Chemical Name:
- 1-(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 1-oxide
- MF:
- C28H54N8O
- Structure:
- Chemical Name:
- Cabozantinib impurity DX2
- CAS:
- 1628530-38-0
- MF:
- C28H24FN3O6
- Chemical Name:
- Selegiline Impurity (224Da)
- Chemical Name:
- Oxybutynin Impurity(MW 481Da)
- Chemical Name:
- Vitamin K1 hydroxylated Impurity
- Chemical Name:
- 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid 4HCl
- Chemical Name:
- Cefdinir CP Impurity F
- Chemical Name:
- Ceftazidime Oxide Impurity 1
- Chemical Name:
- Nifuratel Impurity 21
- Structure:
- Chemical Name:
- Ornidazole Impurity 15
- CAS:
- 105687-87-4
- MF:
- C7H9ClN4O5
- Structure:
- Chemical Name:
- 2-(Dimethylamino)ethyl 4-methylbenzenesulfonate
- CAS:
- 123091-15-6
- MF:
- C11H17NO3S
- Structure:
- Chemical Name:
- Vildagliptin I Impurity
- CAS:
- 1811569-16-0
- MF:
- C7H9IN2O
- Structure:
- Chemical Name:
- Acemetacin EP Impurity D/6-t-Butyl Acemetacin/[[[1-(4-Chlorobenzoyl)-6-(1,1-dimethylethyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetic acid
- CAS:
- 76812-64-1
- MF:
- C25H26ClNO6
- Structure:
- Chemical Name:
- Pregabalin Impurity 38
- CAS:
- 1141362-94-8
- MF:
- C8H15NO2
- Chemical Name:
- Acemetacin Impurity Ｄ
- Chemical Name:
- 6,6'-oxybis(3-formylbenzonitrile)
- Structure:
- Chemical Name:
- 4-乙基-2,3-二氧代-N-苯基哌嗪-1-甲酰胺
- CAS:
- 65322-79-4
- MF:
- C13H15N3O3
- Structure:
- Chemical Name:
- Cucurbitacin IIa 2-O-glucoside
- CAS:
- 77704-34-8
- MF:
- C38H60O13
- Structure:
- Chemical Name:
- Cabozantinib Impurity EXA
- CAS:
- 1431468-36-8
- MF:
- C17H14F2N2O2
- Chemical Name:
- Tafluprost Impurity 13
- Chemical Name:
- GLICLAZIDE IMPURITY B
- Structure:
- Chemical Name:
- ISOPROMETHAZINE HYDROCHLORIDE
- CAS:
- 5568-90-1
- MF:
- C17H21ClN2S
- Structure:
- Chemical Name:
- ZOLPIDEM IMPURITY A
- CAS:
- 1346600-85-8
- MF:
- C19H21N3O
- Structure:
- Chemical Name:
- Carbamic acid, N-[(1S,2S,4S)-2-hydroxy-4-[[(2-methylpropoxy)carbonyl]amino]-5-phenyl-1-(phenylmethyl)pentyl]-, 5-thiazolylmethyl ester
- CAS:
- 1010809-39-8
- MF:
- C28H35N3O5S
- Structure:
- Chemical Name:
- Piperazine, 1,4-bis[2-[(2,4-dimethylphenyl)thio]phenyl]-
- CAS:
- 2243045-82-9
- MF:
- C32H34N2S2
- Structure:
- Chemical Name:
- 2-amino-4-methoxy-5-(3-morpholin-4-ylpropoxy)benzoic acid
- CAS:
- 1640351-46-7
- MF:
- C15H22N2O5
- Structure:
- Chemical Name:
- 3-Desoxyvitamin D3
- CAS:
- 69662-75-5
- MF:
- C27H44
- Structure:
- Chemical Name:
- cis-Vitamin K2
- CAS:
- 65061-19-0
- MF:
- C31H40O2
- Chemical Name:
- N,N'-((5-methylisoxazole-3,4-diyl)bis(3,1-phenylenesulfonyl))dipropionamide disodium salt
- Chemical Name:
- Zanubrutinib Impurity
- Structure:
- Chemical Name:
- (O-Isobutyryl (R)-Fesoterodine
- CAS:
- 1795786-25-2
- MF:
- C30H43NO4
- Chemical Name:
- Cefdinir Degradation Impurity 1
- Chemical Name:
- Cephalexin Impurity C2
- Chemical Name:
- Cefalexin Ethyl Homolog 2 Impurity
- Structure:
- Chemical Name:
- Azlocillin Opern-Ring Impurity
- CAS:
- 96688-41-4
- MF:
- C20H25N5O7S
- Chemical Name:
- Piperacillin Impurity P
- Structure:
- Chemical Name:
- 1,1'-(((2R,2'R,4R,4'R)-4,4'-(oxybis(methylene))bis(2-(2,4-difluoro phenyl)tetrahydrofuran-4,2-diyl))bis(methylene))bis(1H-1,2,4-triazole)
- CAS:
- 2256739-22-5
- MF:
- C28H28F4N6O3
- Chemical Name:
- 8-((R)-1-acryloylpiperidin-3-yl)-10-(4-phenoxyphenyl)-1,10b-dihydropyrazolo[4,3-e]pyrimido[1,2-c]pyrimidin-2(8H)-one
- Structure:
- Chemical Name:
- Levosimendan Impurity 16
- CAS:
- 2290570-69-1
- MF:
- C11H12N2O
- Structure:
- Chemical Name:
- Tolvaptan Impurity 11
- CAS:
- 331947-69-4
- MF:
- C16H14ClNO2
- Structure:
- Chemical Name:
- (S)-2-((R)-2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide
- CAS:
- 2432911-31-2
- MF:
- C11H18N2O3
- Chemical Name:
- Peramivir Impurity 17
- Chemical Name:
- Peramivir Impurity 23
- Structure:
- Chemical Name:
- Silodosin Carboxylic Acid Impurity
- CAS:
- 1431373-77-1
- MF:
- C25H31F3N2O5
- 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:
- 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:
- C10H15NO3.ClH
- Structure:
- Chemical Name:
- (1-methylpiperidin-4-yl)(pyridin-2-yl)methanone
- CAS:
- 517875-04-6
- MF:
- C12H16N2O
- Structure:
- Chemical Name:
- 2-cyano-1,3-bis(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine
- CAS:
- 55272-86-1
- MF:
- C16H24N8S2
- 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
- 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:
- Vigabatrin Impurity 1
- CAS:
- 2324151-81-5
- MF:
- C8H11NO3
- Chemical Name:
- Pramipexole Impurity M
- Chemical Name:
- Premastast Impurity 2