Contents 1 Pinyin 2 English Reference 3 Calcium Gluconate Sodium Chloride Injection Pharmacopoeia Standard 3.1 Product Name 3.1.1 Chinese Name 3.1.2 Chinese Pinyin 3.1.3 English Name 3.2 Source (Name), Content (Effect) Price) 3.3 Characteristics 3.4 Identification 3.5 Inspection 3.5.1 pH value 3.5.2 Heavy metals 3.5.3 Osmolarity 3.5.4 Bacterial endotoxin 3.5.5 Others 3.6 Content determination 3.6.1 Calcium gluconate 3.6.2 Sodium chloride 3.6 .2.1 Preparation of reference substance stock solution 3.6.2.2 Preparation of test solution 3.6.2.3 Determination method 3.7 Category 3.8 Specification 3.9 Storage 3.10 Version 4 Reference 1 Pinyin

pú táo táng suān gài lǜ huà nà zhù shè yè 2 English reference

Calcium Gluconate and Sodium Chloride Injection [2010 Pharmacopoeia] 3 Calcium Gluconate Sodium Chloride Injection Pharmacopoeia Standard 3.1 Product Name 3.1.1 Chinese Name

Glucose Calcium Gluconate and Sodium Chloride Injection 3.1.2 Chinese Pinyin

Putaotangsuangai Lühuana Zhusheye 3.1.3 English name

Calcium Gluconate and Sodium Chloride Injection

3.2 Source ( Name), content (potency)

This product is a sterile aqueous solution of calcium gluconate and sodium chloride. Containing calcium gluconate (C12H22CaO14·H2O) and sodium chloride (NaCl) should be 95.0 to 105.0 of the labeled amount. [1] 3.3 Properties

This product is a colorless, clear liquid. 3.4 Identification

(1) Take an appropriate amount of this product and perform the calcium gluconate identification test (1) to show the same reaction.

(2) This product shows the identification reaction of calcium salt (2), sodium salt and chloride (Appendix III of Part II of the 2010 edition of the Pharmacopoeia). 3.5 Inspection 3.5.1 pH value

should be 4.5 ~ 7.5 (2010 edition of Pharmacopoeia, Part II, Appendix VI H). 3.5.2 Heavy metals

Take 50ml of this product, evaporate to about 20ml, let it cool, add 2ml of acetate buffer (pH 3.5) and an appropriate amount of water to make 25ml, and check according to the law (2010 Pharmacopoeia Part 2 Appendix VIII H First Method), the content of heavy metals shall not exceed 3 parts per 10 million. 3.5.3 Osmolarity

Take this product and check it according to the law (2010 edition of Pharmacopoeia, Part II, Appendix IX G). The osmolality should be 300~380mO***ol/kg. 3.5.4 Bacterial Endotoxins

Take this product and check it according to the law (2010 edition of Pharmacopoeia, Part II, Appendix XII E). The amount of endotoxin contained in each 1ml shall not exceed 0.50EU. 3.5.5 Others

Should comply with the relevant regulations under injections (2010 edition of Pharmacopoeia, Part II, Appendix I B).

3.6 Content determination 3.6.1 Calcium gluconate

Precisely measure an appropriate amount of this product (approximately equivalent to 0.5g of calcium gluconate), place it in a conical flask, dilute with water to make 100ml, add sodium hydroxide and test Add 15 ml of solution and 0.1 g of calcium purpurin indicator, and titrate with disodium ethylenediaminetetraacetate titrant (0.05 mol/L) until the solution changes from purple to pure blue. Each 1ml of disodium ethylenediaminetetraacetate titrant (0.05mol/L) is equivalent to 22.42mg of C12H22CaO14·H2O. 3.6.2 Sodium chloride 3.6.2.1 Preparation of reference substance stock solution

Precisely measure an appropriate amount of sodium single element standard solution and dilute it with water to prepare a solution containing 100ug of sodium ions per 1ml. 3.6.2.2 Preparation of test solution

Precisely measure 5ml of this product, place it in a 100ml measuring bottle, dilute it with water to the mark, shake well, accurately measure 1ml, place it in a 50ml measuring bottle, and add water to dilute it Go to the mark, shake well, and it's ready. 3.6.2.3 Determination method

Precisely measure 0.5 ml, 1 ml, 2 ml, 3 ml and 4 ml of the reference substance stock solution into 100 ml measuring bottles respectively, dilute to the mark with water and shake well. Take each of the above solutions and the test solution, measure it at a wavelength of 589nm according to atomic absorption spectrophotometry (method 2, appendix IV D of the 2010 edition of the Pharmacopoeia), and multiply the calculation results by a conversion factor of 2.5 to get it. [2] 3.7 Category

Calcium supplements. 3.8 Specifications

100ml: 1g calcium gluconate and 0.9g sodium chloride 3.9 Storage

Store in a sealed container away from light. Version 3.10